Tools and Techniques for Effective Clinical Research Start-up at an Academic Medical Center

how to start a medical research project

Abstract : Activating a clinical research project at an academic medical center requires significant planning and effort from study teams. Research sponsors often have difficulty understanding any process lacking in consistency and transparency and so start-up becomes a barrier to study enrollment. This article breaks down such barriers by advocating specific project management and communication tools and techniques that accelerate the study start-up process without sacrificing quality.

Declaring Goals for Study Start-up

Study start-up is the project calibration stage of any clinical research project. There are many rules, regulations, and processes to be followed when conducting clinical research, and so it is essential to first have a strategy for successful completion of a project.

Table 1 highlights the goals for study start-up. From the onset, it is necessary for stakeholders to have a clear understanding of the institutional process as well as the more local program-specific process for study start-up. Individual program areas have their own priorities, so even within the same academic medical center, the start-up can take on a variety of forms, often for good reason. If it is difficult to create a one-size-fits-all model, it is then necessary to cultivate a flexible predictability via organizational consensus, staff training and education, and clear and regular communication with sponsors. Striving to meet sponsor expectations while executing organizational mandates are key objectives during start-up.

Identifying Barriers to Study Start-up

Executing on institutional mandates and minimizing the duration of study start-up are not mutually exclusive goals, but the interplay is often complicated. Institutional mandates account for sound legal, safety, and financial considerations. Study teams must be empowered to promote and act on these goals while also advocating for the priorities of clinical investigators and sponsors who wish to partner on a study.

There can be a lack of predictability in study start-up (Table 2). Portfolio complexity can be a barrier to site activation. For example, UCLA Pediatrics has about a dozen medical sub-specialty divisions conducting clinical research at a given time: clinical trials, retrospective analyses, biorepositories, and longitudinal and non-interventional studies of rare diseases, etc. These divisions can be even further sub-specialized down to the investigator portfolio level.

Perhaps understandably then, there is a great deal of variety in the types of sponsors and research in this space. At a given time, about 50% of our projects are likely to be industry-sponsored, 30-35% non-profit sponsored, and 15-20% collaborative (industry and non-profit involvement). We must be intelligent in the way that we manage this because complexity readily travels into the legal, safety, finance, and operations arenas.

At UCLA, the sponsor types and project types dictate specialized contracting unit workflows. To avoid delays in start-up, knowing which office to engage for support in negotiation of a sponsored agreement is essential.

The Office of Contracts and Grants Administration (OCGA) 2 manages all federally-funded research awards as well as research awards funded by non-profit organizations or the state. This office supports the university at large, not only the health sciences.

UCLA also supports clinical research partnerships with private industry. There are two specialized contracting units for these partnerships:

Clinical Trials Contracts and Strategic Relations (CTC&SR) 3 deals in clinical trial research awards for the investigation of medical devices, biologics, and investigational drugs. This office supports the health sciences specifically.

The Technology Development Group 4 supports industry-sponsored clinical research awards that are not clinical trials. Like OCGA, this office supports the university at large, not only the health sciences.

In instances of for-profit and non-profit partnership, the general process guidelines are modified to suit the needs of the project.

Finance and Operations

Gaining approvals from the variety of ancillary medical services necessary to accommodate all protocol requirements can be another barrier to completing start-up. Upon receiving an application and completing a service analysis, each support unit produces its own budget that will be included in the sponsor’s overall project budget.

A non-exhaustive list of these ancillary service units includes the investigational pharmacy, the clinical and translational research center, clinical radiology, clinical pathology, anesthesia, pheresis and stem cell units, nuclear medicine, ophthalmology, a functional assessment lab, highly specialized core laboratories 5 , a medical device formulary, and a gene and cell therapy manufacturing facility. 6

When sponsor clarification is required, it can be challenging for teams to pull together all of the necessary ancillary service agreements in a timely fashion, but it is essential to the financial and operational success of the project.

Putting aside the well-known and valuable role of medical IRBs in clinical research, and considering for a moment a specific aspect of the process as it relates to the whole, what may not be obvious to sponsors, and which may not be true at all academic medical centers, is the role that the IRB plays in holding its approval back until other important safety or scientific approvals are shown to be in place.

At UCLA, a non-exhaustive list of these other approvals includes committees for internal scientific peer review; medical radiation safety, biosafety, and/or a central IRB approval. If our IRB has not issued its local approval, it may very well intend to do so once these other committees provide theirs. If study teams do not make this distinction clear to sponsors or to colleagues within the organization, the issue may be confused and complicate the overall outlook for start-up at the site.

Ultimately, UCLA requires legal, financial, and safety approvals from study teams in order to undertake a sponsored clinical research study. Project specifics often mandate the path that a project takes, and it is the site’s responsibility to guide sponsors along the selected path.

Tools and Techniques for Effective Study Start-up

Since infrastructure and priorities naturally vary from one organization to the next, in most cases the following recommendations are purposefully general to allow for easy adoption and modification to the specific needs of individuals, programs, and organizations.

Project Management

Organizations recognizing value in an independent project management role may find more success in this landscape than those organizations that do not. This is because the many legal, safety, financial, and operational concerns in start-up must be kept on track to meet start-up goals, and they do not cease with site activation. If existing study team members do not have the ability to do project management because they are tending to other essential responsibilities, like coordinating patient visits for active studies, reporting data to sponsors, and maintaining the regulatory body of ongoing studies, etc., then the site might consider appointing a dedicated project manager to provide effort in this space.

Simple Software

UCLA Pediatrics uses a formulated Microsoft Excel spreadsheet to track administrative and scientific tasks required for study start-up. In addition to providing a reliable space to track our process data, we also have the local flexibility to modify and adjust to the real-time environment. We use this approach to track, among other things, the average length of time that it takes to activate a project in our portfolio. Knowing about how long study start-up takes makes it easier to manage expectations and plan for each new project sent down a similar path. We are also able to measure and target slowdowns in any of the major start-up pathways.

Advanced Software

The more rapid flow of information is essential to start-up. UCLA made a strategic decision to leverage its existing and familiar webIRB system as the front end of a multi-program research continuum called ResearchConnect. 7 The webIRB interfaces with the CTMS, which in turn interfaces with the electronic health record. This fundamentally restructured the study activation pathway from the previous disconnected IRB, finance, and contracting reviews into a parallel review model initiated at the point of webIRB submission. Now legal, safety, and financial reviews happen in parallel, and uniform information is disseminated more broadly to stakeholders, aiming to shorten the period between submissions and approvals to the greatest extent possible without sacrificing quality.

Obvious Communication

Whether using telephone, email, or in-person meetings, or using all three, regular communication and periodic status check-ins have an uncanny way of advancing a project toward approval.

The Single Application Method

Committee applications take all shapes: hard copy forms, emails, online applications, etc. It is necessary to prospectively identify all required study approvals and prepare the applications at once. Use a major deadline for a target, perhaps the IRB’s deadline. Submit all required applications on the same day to establish a uniform starting point. This approach lends predictability to the work: someone will not need to remember to get something else in later when other approvals may depend on it. One will most likely have their minor approvals in hand when they need to provide them for major approvals. This approach brings alignment and quiet to an unruly information exchange.

Create a Checkpoint

About a month after submission (or sooner if to needed), plan to meet with project stakeholders to ensure completion of initial tasks and to discuss the final steps to be taken to complete start-up. At UCLA Pediatrics, this meeting has taken the form of a finance committee meeting in which we gather ancillary service approvals with cost estimates and present the budget for PI review. We also take it as an opportunity to remind ourselves that we must push ahead with energy to reach the finish line.

Completion of Start-up

Tying up loose ends is easier said than done. As one nears the end of the start-up period, one should not be ashamed to over communicate the team’s desire to complete the agreement. Involve all necessary parties in a single conversation so that nothing is missed. Keep in mind that we do not do clinical research because start-up is a grand challenge; we do start-up so that we may do clinical research.  

Declaring the goals for study start-up at the onset is the first step toward clinical trial success, but then, execution and tenacious follow-through are key elements of reaching goals. Study teams should actively engage stakeholders within the organization, and the sponsor, to ensure understanding of the study-specific needs and organizational requirements. Study teams should also employ tools and techniques to keep all parties engaged as necessary throughout study start-up so as to reach an agreement as quickly as possible. One success leads to another!

#          #          #

Goals for Study Start-Up

  • Meeting sponsor expectations
  • Executing on institutional mandates
  • Stakeholder understanding of the process
  • Identifying and overcoming project complexities

Barriers to Study Start-Up

  • Specialization vs. Standardization
  • Contracting according to project types and sponsor types
  • Specialized ancillary support services and budgeting
  • Diffused safety and scientific committee approvals

Tools and Techniques for Effective Study Start-Up

  • Program trackers
  • Software applications
  • Communications
  • “Single application” method
  • Follow-through

4 thoughts on “Tools and Techniques for Effective Clinical Research Start-up at an Academic Medical Center”

Your article really piqued my curiosity. I had to consider some of your unique ideas in order to think about them a bit. I agree in part with your views. Thank you for interesting content.

it is easy to make a goal in clinical research but hard to execute. there are some unique ideas in this blog. thank you.

hey it looks important. greatly defined meaning of clinical research. thank you for sharing.

Streamlining the study start-up process through effective project management and communication tools is crucial for accelerating clinical research projects. Clear goals, proactive identification of barriers, and the implementation of appropriate techniques can enhance efficiency and collaboration, ultimately leading to successful study execution.

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AMBOSS Blog

  • Student Life

How to Write and Publish Clinical Research in Medical School

A woman's hands typing her clinical research paper beside a notebook and papers.

From working hard on the USMLE® exams to holding leadership positions in a specialty’s academic society, there are many ways medical students can work towards matching into the residency of their choice. One such activity that looks great on residency applications is finding clinical research opportunities in medical school to write and publish papers. No one knows this better than Dr. Eve Bowers. 

An Otolaryngology resident at the University of Miami/Jackson Memorial Hospital, Eve became an expert in writing, submitting, and publishing manuscripts during her final years in medical school. Check out Eve’s blog post below to get valuable insights on how to get published in medical school. 

As medical students, we’re told that research is important and that publications are “good”, and even “necessary to match ” into residency, but we often aren’t given the tools we need to turn ideas into manuscripts. This is especially true given our rigorous schedules. 

When I looked through my CV, I saw I had a few abstracts and presentations, but no manuscripts. I wanted to write, but publishing seemed like just checking another resume box. On top of that, I didn’t know where to begin. 

My writing journey started with a case report I nervously picked up during my surgery clerkship . Then, over ten months of typing, editing, and sending unanswered emails, I went from writing 0 to ten manuscripts. The process was sometimes painful but mostly gratifying (yes, research can be gratifying), and you can do it, too.

To make finding, starting, and publishing high-quality research articles a little bit easier and a lot more enjoyable, check out my five tips for publishing clinical research in medical school.

1. Build your network to find publication opportunities in medical school

When looking for projects, finding great mentors is often more useful than finding the perfect project. This is especially true when starting out. Use your time on clerkships to identify attending and resident mentors who you trust to support your budding author ambitions.

At this stage, residents especially are your friends . When you demonstrate follow-through and receptiveness to feedback, you will be given more research opportunities. Don’t be shy about asking mentors for tasks if you can juggle multiple projects, but don’t bite off more than you can chew. It’s important to communicate honestly and be transparent about the amount of time you have.

2. Kickstarting your research during medical school: start small 

If you have no research experience, start with a case report. Volunteer to write an article about an interesting case you saw in the operating room or clinic. It’s much easier and more rewarding to write about patients you have experience with, and case reports are a great way to demonstrate your writing ability to more senior authors.

Pro tip : Try to figure out as much as you can independently by using published reports as blueprints before asking for help. Nevertheless, don’t be afraid to seek guidance when you need it! If you approach a mentor with a problem, come prepared with 2-3 realistic solutions or examples of how you tried to figure it out on your own.

3. Know the criteria for writing a clinical research paper 

Before you begin, ask your mentor where they would like to submit the completed work. Each journal has specific standards, styles, and submission criteria. For guidance, look to papers previously published in that journal. 

As far as annotations and citations are concerned, download and learn how to use Endnote or Zotero right now! You’ll save days of work formatting your references.

Additionally, consider creating folders and spreadsheets to keep track of projects. Set goals and timelines for yourself from the beginning, and block off dedicated time to conduct a literature review, analyze data, and write.

Pro tip : If you are the first author and overseeing a large team, improve communication and efficiency by making everyone’s roles and expectations very clear to the group via email.

4. Follow up with your mentor

Sometimes you’ll send your mentor a draft, but she won’t get back to you with edits and feedback in a reasonable timeframe. Surprisingly, many projects do not get past this point because of insufficient persistence. Here’s what to do if this happens:

  • Politely nudge your mentor with follow-up emails and schedule a meeting to discuss in person or via Zoom.
  • Set deadlines and give specific reasons why the paper needs to be submitted. Some reasons could include, “I need this submission for my residency application ” or “this is a requirement for my school.”
  • Ask your co-author resident and/or fellow to advocate for edits and submission.

Whatever happens, don’t give up at this point. You’ve put in the work, and persistence makes or breaks a successful student-author.

5. Write about the medical topics that you love

Writing is fun when you focus on subjects you’re really passionate about. You also don’t have to stay within your institution: feel free to branch out if you come across an interesting research opportunity at a different program. A little cold email can go a long way!

If your goal is quantity, you can increase output by asking around about “productive” research mentors and sticking to topics related to clinical practice or medical education. However, my advice is to never let relatively quick publication opportunities compromise the quality of your work. Remember — every paper you write gets easier and more enjoyable, and your work will be truly important to advancing the field you care about. Good luck!

Eve Bowers who wrote 10 clinical research papers in medical school.

About the Author : Eve is an Otolaryngology Resident at the University of Miami/Jackson Memorial Hospital. She attended medical school at the University of Pittsburgh School of Medicine and undergrad at the University of Pennsylvania. She is passionate about medical education, mentorship, and increasing minority and female leadership in surgical fields. For more tips and tricks, follow her on Twitter and Instagram !

For more information on residency applications, check out the AMBOSS Residency Applications Clerkship Survival Guide. 

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  • Knowledge Base
  • Starting the research process

A Beginner's Guide to Starting the Research Process

Research process steps

When you have to write a thesis or dissertation , it can be hard to know where to begin, but there are some clear steps you can follow.

The research process often begins with a very broad idea for a topic you’d like to know more about. You do some preliminary research to identify a  problem . After refining your research questions , you can lay out the foundations of your research design , leading to a proposal that outlines your ideas and plans.

This article takes you through the first steps of the research process, helping you narrow down your ideas and build up a strong foundation for your research project.

Table of contents

Step 1: choose your topic, step 2: identify a problem, step 3: formulate research questions, step 4: create a research design, step 5: write a research proposal, other interesting articles.

First you have to come up with some ideas. Your thesis or dissertation topic can start out very broad. Think about the general area or field you’re interested in—maybe you already have specific research interests based on classes you’ve taken, or maybe you had to consider your topic when applying to graduate school and writing a statement of purpose .

Even if you already have a good sense of your topic, you’ll need to read widely to build background knowledge and begin narrowing down your ideas. Conduct an initial literature review to begin gathering relevant sources. As you read, take notes and try to identify problems, questions, debates, contradictions and gaps. Your aim is to narrow down from a broad area of interest to a specific niche.

Make sure to consider the practicalities: the requirements of your programme, the amount of time you have to complete the research, and how difficult it will be to access sources and data on the topic. Before moving onto the next stage, it’s a good idea to discuss the topic with your thesis supervisor.

>>Read more about narrowing down a research topic

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So you’ve settled on a topic and found a niche—but what exactly will your research investigate, and why does it matter? To give your project focus and purpose, you have to define a research problem .

The problem might be a practical issue—for example, a process or practice that isn’t working well, an area of concern in an organization’s performance, or a difficulty faced by a specific group of people in society.

Alternatively, you might choose to investigate a theoretical problem—for example, an underexplored phenomenon or relationship, a contradiction between different models or theories, or an unresolved debate among scholars.

To put the problem in context and set your objectives, you can write a problem statement . This describes who the problem affects, why research is needed, and how your research project will contribute to solving it.

>>Read more about defining a research problem

Next, based on the problem statement, you need to write one or more research questions . These target exactly what you want to find out. They might focus on describing, comparing, evaluating, or explaining the research problem.

A strong research question should be specific enough that you can answer it thoroughly using appropriate qualitative or quantitative research methods. It should also be complex enough to require in-depth investigation, analysis, and argument. Questions that can be answered with “yes/no” or with easily available facts are not complex enough for a thesis or dissertation.

In some types of research, at this stage you might also have to develop a conceptual framework and testable hypotheses .

>>See research question examples

The research design is a practical framework for answering your research questions. It involves making decisions about the type of data you need, the methods you’ll use to collect and analyze it, and the location and timescale of your research.

There are often many possible paths you can take to answering your questions. The decisions you make will partly be based on your priorities. For example, do you want to determine causes and effects, draw generalizable conclusions, or understand the details of a specific context?

You need to decide whether you will use primary or secondary data and qualitative or quantitative methods . You also need to determine the specific tools, procedures, and materials you’ll use to collect and analyze your data, as well as your criteria for selecting participants or sources.

>>Read more about creating a research design

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Finally, after completing these steps, you are ready to complete a research proposal . The proposal outlines the context, relevance, purpose, and plan of your research.

As well as outlining the background, problem statement, and research questions, the proposal should also include a literature review that shows how your project will fit into existing work on the topic. The research design section describes your approach and explains exactly what you will do.

You might have to get the proposal approved by your supervisor before you get started, and it will guide the process of writing your thesis or dissertation.

>>Read more about writing a research proposal

If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

Methodology

  • Sampling methods
  • Simple random sampling
  • Stratified sampling
  • Cluster sampling
  • Likert scales
  • Reproducibility

 Statistics

  • Null hypothesis
  • Statistical power
  • Probability distribution
  • Effect size
  • Poisson distribution

Research bias

  • Optimism bias
  • Cognitive bias
  • Implicit bias
  • Hawthorne effect
  • Anchoring bias
  • Explicit bias

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Med School Insiders

Comprehensive Guide to Research from the Perspective of a Medical Student

  • By Dmitry Zavlin, M.D.
  • February 9, 2017
  • Medical Student , Pre-med

G uest post from Dmitry Zavlin, MD, a research fellow in Houston, Texas. He has been highly productive in his research endeavors and below describes a comprehensive guide to getting involved in research.

Without any doubt whatsoever, high USMLE scores, strong recommendation letters from faculty members, a multitude of away rotations, and an updated and accurate résumé make up the foundation of a strong application for a residency position. Nevertheless, from my personal experience, one topic remains crucial that many medical students either love or hate (or try not to think about it): research . It is an extracurricular activity that enables someone to stand out from the crowd and present oneself as a diverse and multitasking character. These traits are especially favorable when it comes to applying to competitive residency programs with high applicant to position ratios. I encourage every future graduate to look into this topic since – and as astonishing as this may seem – medical school is the ideal opportunity to get your name out there. You don’t need to take a year off from classes or be on an M.D., Ph.D. track. Even those students that do not seek academic careers have a benefit from engaging in scientific duties . It helps you understand the mechanisms of research, the bureaucratic obstacles, the medical challenges, and teaches you communication with peers and faculty. Furthermore, you learn how to read, analyze, and interpret scientific publications of others. And trust me, it’s not all gold that gets printed in journals . On first glance, getting involved in unpaid ventures while you are in class, on rotation, at home studying or just taking some time off for yourself might seem like a bad deal. Yet with a sincere approach towards this subject, you can strengthen your résumé, top off your application, and learn skills that will serve you well into your career as a doctor.

The following lines are intended to display my personal experience that I have made at my medical school and in my interactions with students, residents, fellows, and attendings at my current position.

Choosing your Project

First things first. Naturally, you would want to participate and conduct research in a field of medicine you might see yourself in after graduation. However, as mentioned before, this is not a K.O. criterion. Plenty of personal experiences tell me stories of students who were involved in one area and then switched and matched in a completely different specialty of medicine or completely left the patient-care sector. Therefore, consider your engagement in scientific tasks more of as a symbolization for your work ethic and your ability to perform in a team.

My first tip is to contact the department at your home medical school, introduce yourself, write 1-2 sentences describing your motivations and goals, and ask to sit down with some faculty members or scientific staff to discuss your involvement in any research activities.

Larger departments usually have secretaries or an academic office where your email is less likely to get lost compared to the inbox of a busy professor who receives hundreds of emails per day. Personally, I would aim for junior faculty and potentially senior residents who are experienced enough to conduct research on a high level but are not too far away from the life of a young medical student. Certain departments further have specific full-time research staff that is definitely a great resource for any scientific venture. While it may be helpful to work with the director and senior faculty directly, the sad reality is often that they typically have many academic and administrative duties and activities at their institutions that might not go along well with the schedule of an ambitious student and cause frustration in the long run.

When you meet, make sure to gain and write down as many details as possible:

  • What is the topic, what is the goal of this project?
  • What type of format is it? (See below)
  • What is the current status?
  • Who is involved in this research project, what is the team, what are the people to contact?
  • What will be my duties?
  • Any bureaucratic issues to be aware of (IRB approval, grants, finances)?
  • What is the prognosis? Are there any deadlines?

Lastly, ask about the current literature on that topic so you know what your team’s role is going to be in this scientific field. Although one core concept of any research result is reproducibility, it often remains a challenge to publish a project that has already been performed and presented or printed before. Getting involved in an area that is in quick development with high turnaround is subsequently a strong recommendation.

Types of Evidence-Based Research

Now, I would like to talk about the most common options you will encounter when presented with an array of project offers. That way you know their perks and pitfalls before you commit to anything serious and long-lasting and potentially even waste any valuable and limited time of yours.

  • Case Reports: These are the most basic and least powerful of scientific contributions to medicine. Give or take, a case report is the summarized hospital or clinic chart of a treated patient who presented with a problem A and was managed with therapy B. A case report that is typically 2-3 pages long with a short intro, a compact case discussion, and perhaps some photos is the closest thing you will get to a patient note you learned to write in early medical school. Their lack of medical value makes them hard to get published in journals and students should not solely rely on these projects as they may not ultimately be accepted by journals. Recommendation: 3/5
  • Case Series, Retrospective Study: These layouts are my personal recommendation as they allow quality results within a short period and are not time-consuming or require large long-term commitment as others. Typical examples are an analysis of patients who presented with the same diagnosis or underwent an identical procedure. The difference between a case series and a retrospective study is that for the latter, the patients can be stratified into different subgroups (similar to “case control study”) and statistical calculations can be performed to achieve significant conclusions. Recommendation: 5/5
  • Prospective Studies: In these studies, patients are gathered in one or multiple cohorts and are followed-up over long periods of time by lab results, imaging, physical exams etc. These require great time commitment and, from a student perspective, typically only allow a certain amount of participation. These are usually studies for physicians with long relationships with their patients. Recommendation: 3/5
  • (Randomized) Clinical Trials : The peak of evidence-based medical research. Similar as prospective studies yet require more planning, IRB approval, and lots of work with industry, grants, protocols, etc. Student involvement is usually marginal. Recommendation: 2/5
  • Basic Science, Animal Work: Although these projects require training, approval, and a large amount of preparation, student participation is common in many areas of basic science. The advantage of these laboratory activities is a certain amount of flexibility on when certain tasks and duties can be performed. Within certain limitations, a medical student can get involved in animal or basic science research and assist in specific jobs suitable to his or her personal schedule. Even partial involvement can be enough to get one’s name on a publication. However, lab work can be monotonous and frustrating at times when experiments do not deliver the anticipated results. Sitting in non-stimulation laboratories requires a certain type of character. Recommendation: 4/5
  • Descriptions of Innovations: Purely descriptive publications of new surgical techniques, innovative technology, new pharmaceutical drugs, or simply personal statements on evolving subjects, etc. This type of work often demands a given level of expertise and is not typically suitable for graduate research. Recommendation: 2/5
  • Reviews, Meta-Analyses: These types of written compositions are based on a literature review. The author’s job is to read through countless, often hundreds of previous publications and create a summary regarding a specific medical topic. Reviews and meta-analysis are particularly useful for issues that are prevalent and have delivered many reports in the past. Whereas a review merely lists the findings of previous research groups, a meta-analysis is able to pool data and conduct statistical analyses. These projects allow great flexibility and can be finished from any location but do not underestimate the time needed to achieve proper results. Recommendation: 4/5

Formats of Publication

What follows is a list of mediums that allow you to get your work to the public. Albeit the concept of most research activities is similar and progresses on akin paths, it is important to agree on a goal early in the research process. Journal articles, for example need to be of highest quality and impeccable when submitted. Presentations must be tailored accordingly depending on what audience you are planning to address. Book chapters need clear guidelines to ensure that your handiwork fits well to the other parts of the volume. Make sure to discuss this topic with your seniors to understand their expectations from you.

  • Journal Articles: These are the highest quality format that you can use to submit your research work for the world to see. Upon arrival at the journal’s office, the editorial office first reviews your manuscript and determines its eligibility. Next, it is sent off to a number of anonymous reviewers who judge your documents and suggest if it is worth publication, if it needs changes, or if it should be rejected. Being an author on articles in peer-reviewed journal is the strongest support to improve your application. Recommendation: 5/5
  • Podium Presentations: These are typically 5-15min PowerPoint conferences or similar in front of regional, national, and international audiences of students, residents, nurses, scientists, and board-certified physicians. While your work might be less accessible to the world than published articles, it is still recommended to submit your accomplishments to such conventions. Aim for national conferences rather than regional ones. Recommendation: 4/5 for (inter)national, 3/5 for regional conferences
  • Poster Presentations: A classic poster session is where you travel to a conference, hang your poster with a summary of your research findings (similar to a short abstract) and are available for others to review your work and ask questions. In some cases, poster sessions are requested by conferences when you apply for podium presentations but your projects are not considered beneficial enough. Recommendation: 3/5
  • Book Chapters: Senior physicians, faculty members, or experts on a certain field are sometimes asked to write segments of medical or scientific books that are soon to be brought on sale to the market. In certain cases, students or residents write segments of such book chapters for the senior author. From personal experience, these projects are a long-term process as they go into extreme medical detail. On the upside, publication with your name on it is almost guaranteed. Unfortunately, these types of publications are not of high evidence-based research and should only be considered as a secondary side project Recommendation: 3/5

Basic and Necessary Know-How

After choosing your project you need to learn and understand how the scientific process works once you have your results ready for publication. Conducting the studies, experiments, and the literature reviews is one part of the research job. Presenting your findings is the other side of the coin. Read many publications on the same subject and study what a paper is supposed to look like. Analyze the language the authors use. It has to be straight to the point, factual, objective, leave out unnecessary information yet avoid long soporific segments of repeating details. Your audience will want to hear a hypothesis, the methodology of your venture on how said hypothesis should be tested, your results, and an antiseptic interpretation thereof. Having a senior writer review your work is therefore crucial in the beginnings of a research career.

Next, and this may seem like a no-brainer, learn how to properly and efficiently use today’s available technology to your advantage. Learn the most important features of your word processing software. Get access to a tool that allows to sort and list literature references and full versions of articles, preferably in PDF format. If you share files with others or work simultaneously at different sites, use a cloud service to keep your files in synchronization across all your devices. Any photo, video, or graph-editing software with some artistic skills might come in handy as well. Lastly, learn some basic mathematical and statistical skills and obtain a statistical software. Research is nothing if you cannot back up your story by some hard numbers. Study what a t-test, a type I error, and a type II error are and how they work. Understand when you have to use chi-square and when the Fisher’s exact test . This list goes on and on. You do not need a Ph.D. degree in biometrics or stochastic calculus to be involved in medical research but even basic skills can set you far ahead of others and you will stand out from the crowd. Additionally, all these things I just mentioned facilitate your projects by incredible amounts and allow you to publish your results faster. Capitalize on the technology that is available today!

Finally, learn how to revise current literature and how to look for references to back up your ideas or contrast your data to those of other groups. In the end, research is a competition almost like any other business sector; except that money is not necessarily the number one objective but rather prestige and impact.  Pubmed is a valuable search engine, for instance, that allows you to go through the MEDLINE database and find similar publications to your project. UpToDate is a practical tool that is constantly refreshed by countless experts and gives access to the latest guidelines on specific topics. One of my former attendings always said that publishing a paper is like selling a car: you have to know the market and emphasize the upsides of your work to gain interest of others. Have all these files clean and tide on your computer from day 1, so you can keep a good overview of things and track your progress.

Further Aspects to Consider

When you start a new research project, figure out who your team is that you will be working with as this will determine the authors and their order on a potential publication. Make sure your name appears on the final manuscript if you have brought significant effort and input towards the project. As the New England Journal of Medicine, one of the largest and most prestigious journals in the field, states:

“Credit for authorship requires (a) substantial contributions to the conception and design; or the acquisition, analysis, or interpretation of the data, (b) the drafting of the article or critical revision for important intellectual content, (c) final approval of the version to be published, and (d) agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the article are appropriately investigated and resolved.”

The more work you put in, the further your name should appear up front. The final position of a scientific publication is usually reserved for the senior author (principal investigator) and the head of the team.

The last issue that needs to be mentioned here are finances. Even if you are working on a retrospective study and are just simply scrolling through patient charts to gather data, special software, travel to conferences, fees for journals (author processing charge for open access) can rapidly add up. Basic science ventures may require additional funding. Knowing your resources is crucial for any research. The discussion of money may seem like a sensitive subject and “above your pay grade” yet I recommend approaching this topic with open cards when the right moment comes.

Final Words

Despite the downsides of scientific work, I still believe the majority of students should experience the art of research that has made medicine what it is now. Yes, research is frequently frustrating and consumes many of your physical and mental resources. Yes, a majority of jobs after residency do not include research. Still, I will never forget the great feeling of my first accepted publication and when I immediately continued to strive towards the next challenge. Henceforward, research had something rewarding and appealing about it. In the long run, this highly dynamic profession is probably not suited for all future physicians, yet I can only repeat myself and encourage everyone to give it a try.

Dmitry Zavlin graduated with an M.D. from the Technical University of Munich in 2015.

He currently works as a research fellow in Houston.

To contact the author, please visit www.zavlin.com

Dmitry Zavlin, M.D.

Dmitry Zavlin, M.D.

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Medical school is a completely different beast from your pre-med years in college. Here are four things you should know and prepare for in order to have the most productive, effective, and happy experience of medical school!

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Premed and Medical Student Summer Research Guide

We break down the value of summer research, how to find research positions, and tips to make the most of summer research opportunities.

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How to Find an Undergraduate Research Position

Research is a crucial component of any medical school application. Utilize the following tips to streamline the process of finding an ideal research position.

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  • Anna Kathryn Taylor , final year medical student 1 ,
  • Sarah Purdy , professor of primary care and associate dean 1
  • 1 Faculty of Health Sciences, University of Bristol, UK

Participating in research gives students great skills and opportunities. Anna Taylor and Sarah Purdy explain how to get started

This article contains:

-How to get involved with research projects

-Questions to ask yourself before starting research

-What can you get published? Research output

-Advice for contacting researchers

-Different types of research explained

-Stages of research projects

Students often go into medicine because of a desire to help others and improve patients’ physical and mental wellbeing. In the early years of medical school, however, it can seem as if you are not making much difference to patient care. Involvement in research can provide exciting opportunities to work as part of a team, improve career prospects, and most importantly add to the evidence base, leading to better outcomes for patients.

Research is usually multidisciplinary, including clinical academics (medical doctors who spend part of their working life doing research), nurses, patients, scientists, and researchers without a medical background. Involvement in such a team can improve your communication skills and expand your understanding of how a multidisciplinary team works.

Participating in research can also help you to develop skills in writing and critical appraisal through the process of publishing your work. You may be able to present your work at conferences—either as a poster or an oral presentation—and this can provide valuable points for job applications at both foundation programme and core training level. This is particularly important if you are considering a career in academia. You will also develop skills in time management, problem solving, and record keeping. You might discover an area of medicine in which you are keen to carry out further work. For some people, getting involved in research as a medical student can be the first step in an academic career.

Kyla Thomas, National Institute for Health Research clinical lecturer in public health at the University of Bristol, says, “my first baby steps into a clinical academic career started with a research project I completed as a medical student. That early involvement in research opened my eyes to a whole new world of opportunities that I never would have considered.

“Importantly, participating in undergraduate research sets students apart from their colleagues. Applying for foundation posts is a competitive process and it is a definite advantage if you have managed to obtain a peer reviewed publication.”

Getting involved with research projects

Although it is possible to do research at medical school, it is important to be realistic about how much free time you have. It might be possible to set up your own research project, but this will require substantial planning in terms of writing research protocols, gaining ethical approval, and learning about new research methodologies. Other opportunities for research that make less demands on your time include:

Intercalated degrees—these often have time set aside for research in a specific area, so it is important to choose your degree according to what you might like to do for your dissertation (for example, laboratory-based work in biochemistry, or qualitative research in global health. Some subjects may have options in both qualitative and quantitative research).

Student selected components or modules can provide a good opportunity to be involved in an ongoing study or research project. If you have a long project period, you might be able to develop your own small project.

Electives and summer holidays can also provide dedicated time for research, either within the United Kingdom or in another country. They can allow you to become established in a research group if you’re there for a few weeks, and can lead to a longstanding relationship with the research group if you continue to work with them over your medical school career.

If you don’t know what to do, contacting the Student Audit and Research in Surgery (STARSurg), 1 the National Student Association of Medical Research (NSAMR), 2 or your medical school’s research society may be a good place to start.

The INSPIRE initative, 3 coordinated by the Academy of Medical Sciences, gives support and grants to help students take part in research. Some UK medical schools have small grants for elective and summer projects, and organise taster days for students to get an idea of different research areas.

You may also be able to access other grants or awards to support your research. Some of the royal colleges, such as the Royal College of General Practitioners and the Royal College of Psychiatrists, offer bursaries to students doing research in their holidays or presenting at conferences. Other national organisations, such as the Medical Women’s Federation, offer bursaries for elective projects.

Box 1: Questions to ask yourself before starting research

What are you interested in? There is no point getting involved in a project area that you find boring.

How much time do you have available? It is crucial to think about this before committing to a project, so that your supervisor can give you an appropriate role.

What do you want to get out of your research experience? Do you want a brief insight into research? Or are you hoping for a publication or presentation?

Do you know any peers or senior medical students who are involved in research? Ask them about their experiences and whether they know of anyone who might be willing to include you in a project.

Box 2: Research output

Publication —This is the “gold standard” of output and usually consists of an article published in a PubMed ID journal. This can lead to your work being cited by another researcher for their paper, and you can get up to two extra points on foundation programme applications if you have published papers with a PubMed ID.

Not all research will get published, but there are other ways to show your work, such as presenting at conferences:

Oral presentation —This involves giving a short talk about your research, describing the background, methods, and results, then talking about the implications of your findings.

Poster presentation —This involves creating a poster, usually A1 or A2 in size, summarising the background, methods, and results of your research. At a conference, presenters stand by their poster and answer questions from other delegates.

Contacting researchers

Most universities have information about their research groups on their websites, so spend some time exploring what studies are being carried out and whether you are interested in one of the research topics.

When contacting a member of the research group, ask if they or someone else within their team would be willing to offer you some research experience. Be honest if you don’t have any prior experience and about the level of involvement you are looking for, but emphasise what it is about their research that interests you and why you want to work with them. It’s important to have a flexible approach to what they offer you—it may not initially sound very exciting, but it will be a necessary part of the research process, and may lead to more interesting research activity later.

Another way to make contact with researchers is at university talks or lectures. It might be intimidating to approach senior academics, but if you talk to them about your interest they will be more likely to remember you if you contact them later on.

Box 3: What can students offer research teams?—Views from researchers

“Medical students come to research with a ‘fresh eyes’ perspective and a questioning mindset regarding the realities of clinical practice which, as a non-medic myself, serves to remind me of the contextual challenges of implementing recommendations from our work.”

Alison Gregory, senior research associate, Centre for Academic Primary Care, University of Bristol, UK.

“Enthusiasm, intelligence, and a willingness to learn new skills to solve challenges—bring those attributes and you’ll be valuable to most research teams.”

Tony Pickering, consultant anaesthetist and Wellcome Trust senior research fellow, University of Bristol, UK.

Box 4: Different types of research

Research aims to achieve new insights into disease, investigations, and treatment, using methodologies such as the ones listed below:

Qualitative research —This can be used to develop a theory and to explain how and why people behave as they do. 4 It usually involves exploring the experience of illness, therapeutic interventions, or relationships, and can be compiled using focus groups, structured interviews, consultation analysis, 5 or ethnography. 6

Quantitative research —This aims to quantify a problem by generating numerical data, and may test a hypothesis. 7 Research projects can use chemicals, drugs, biological matter, or even computer generated models. Quantitative research might also involve using statistics to evaluate or compare interventions, such as in a randomised controlled trial.

Epidemiological research —This is the study of the occurrence and distribution of disease, the determinants influencing health and disease states, and the opportunities for prevention. It often involves the analysis of large datasets. 4

Mixed methods research —This form of research incorporates both quantitative and qualitative methodologies.

Systematic reviews —These provide a summary of the known evidence base around a particular research question. They often create new data by combining other quantitative (meta-analysis) or qualitative (meta-ethnography) studies. They are often used to inform clinical guidelines.

Box 5: Stages of research projects

Project conception—Come up with a hypothesis or an objective for the project and form the main research team.

Write the research protocol—Produce a detailed description of the methodology and gain ethical approval, if needed.

Carry out the methodology by collecting the data.

Analyse the data.

Decide on the best way to disseminate your findings—for example, a conference presentation or a publication—and where you will do this.

Write up your work, including an abstract, in the format required by your chosen journal or conference.

Submit . For conference abstracts, you may hear back swiftly whether you have been offered the chance to present. Publication submissions, however, must be peer reviewed before being accepted and it can take over a year for a paper to appear in print.

Originally published as: Student BMJ 2017;25:i6593

Competing interests: AKT received grant money from INSPIRE in 2013.

Provenance and peer review: Not commissioned; externally peer reviewed.

  • ↵ STARSurg. Student Audit and Research in Surgery. 2016. www.starsurg.org .
  • ↵ NSAMR. National Student Association of Medical Research. 2016. www.nsamr.org .
  • ↵ The Academy of Medical Sciences. About the INSPIRE initiative. 2016. www.acmedsci.ac.uk/careers/mentoring-and-careers/INSPIRE/about-INSPIRE/ .
  • ↵ Ben-Shlomo Y, Brookes ST, Hickman M. Lecture Notes: Epidemiology, Evidence-based Medicine and Public Health. 6th ed . Wiley-Blackwell, 2013 .
  • ↵ gp-training.net. Consultation Theory. 2016. www.gp-training.net/training/communication_skills/consultation/consultation_theory.htm .
  • ↵ Reeves S, Kuper A, Hodges BD. Qualitative research methodologies: ethnography. BMJ 2008 ; 337 : a1020 . doi:10.1136/bmj.a1020   pmid:18687725 . OpenUrl FREE Full Text
  • ↵ Porta M. A Dictionary of Epidemiology. 5th ed . Oxford University Press, 2008 .

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How to Plan and Design a Clinical Research Project

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Scientific research is in fact the systematic process of collecting and analyzing data in order to increase the available knowledge on a specific field of interest. To start with it is mandatory that a protocol be established and understood by all personnel involved in the research. This protocol must be approved by an Institutional Review Board (IRB) before the research starts off. The research protocol is a formal written document specifying the study design and the manner in which it will be conducted. It is the blueprint of the study and serves as a guideline throughout the implementation and analysis phases. It details procedures to be followed yielding valid results. The research protocol fulfils scientific, ethical, and organizational requirements so that the study may be conducted efficiently and according to the plan, thus standardizing the procedures for research personnel to follow. The purpose of the study and the setting will determine which professionals will be consulted about the development of the research protocol. Subject area experts, epidemiologists, and/or statisticians can be included.

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Clayton D, Hills M (1993) Statistical models in epidemiology. Oxford University Press, United Kingdom

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Daly LE, Bourke GJ (2000) Interpretation and uses of medical statistics. Blackwell Science, United Kingdom

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Hulley S, Cummings S, Browner W et al (2007) Designing clinical research. Lippincott Williams & Wilkins, United States of America

Kirkwood BR, Sterne JAC (2003) Medical Statistics. Blackwell Science, United Kingdom

Leedy PD (1997) Practical research planning and design. Prentice Hall, United States of America

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Zin, A.A., Gullo, A., Zin, W.A. (2009). How to Plan and Design a Clinical Research Project. In: Gullo, A., Lumb, P.D., Besso, J., Williams, G.F. (eds) Intensive and Critical Care Medicine. Springer, Milano. https://doi.org/10.1007/978-88-470-1436-7_41

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How to Get Involved in Research As A Medical Student

  • by Dr. Mike Ren
  • Apr 11, 2023
  • Reviewed by: Amy Rontal

how to start a medical research project

It goes without saying that getting involved in research as a medical student, while an important part of the medical school experience , can also be an intimidating prospect. Not only are you balancing a hectic schedule, but it’s tough to know how (and where) to get started.

So, how exactly do you secure an appropriate, fulfilling research opportunity that will enhance your residency application and put you on track for success? To answer that question, we’ll walk through the absolute fundamentals of pursuing research as a medical student. 

Commitment, Benefits, and Where to Begin

What are the advantages of participating in research as a medical student.

As mentioned, r esearch is an important component of the residency application. Particularly, if you are interested and invested in a particular aspect of medicine or if you want to match into a competitive specialty or at a nationally-ranked academic institution. 

Research experience helps to strengthen a resume and allows candidates to fill in for gaps in their application. For instance, an academic program director might be willing to overlook an applicant’s marginal pass on an elective rotation if that applicant demonstrates strong participation in research. This is not a “magic bullet” to matching with a residency program, however—the priority here is still pass your rotations and national licensing exams.

Further, some applicants find research opportunities so appealing that they even take a research year to churn out publications and present at national conferences. Quality and quantity are both important in terms of publications and presentations. Participating in research as a medical student can help you network as well, further advancing your career in medicine, academia, or industry.

So, how do you get into a research project that eventually yields publications and acclaim?

How much of a time commitment is research?

Look, I get it. You’re a busy medical student. Last week you prepared in order to lead a women’s health interest group meeting, this week you have those pesky histology lectures to catch up on, and next week is a particularly intimidating anatomy practical.  Not to mention, you haven’t had a date night with your significant other since Valentine’s Day because you’ve been busy with your pharmacology study group, and you still have to call your mom.

How will you possibly have time for research in an already hectic MS1 year and how much time should you allot to the cause? 

To put things into perspective, keep in mind that research time ranges from entire month-long electives to a more longitudinal approach. The most common is longitudinal research— this involves working on a project a few hours a week over the course of 6-18 months, typically with a few dedicated weeks near completion to make the publishing deadline. Busy students should dedicate around 10-20 hours weekly for tasks such as obtaining IRB approval, reviewing charts, or writing drafts. 

Alright, I’m interested. Where do I start?

You’ve heard this before. “Just ask!” Often, it’s as simple as that. Create opportunities for yourself by being enthusiastic and inquisitive. Seek out attendings or residents on your rotations, ask if there are any research projects they know of or are involved in. Research is a team effort, and oftentimes, residents will have unfinished projects that could use the help of a medical student to complete. 

Another common finding is that graduating students or students who’ve changed interests do not wish to further continue their projects. This can be a great place to pick up where they left off, as some of the work may already be finished before you even start. (As a disclaimer for this approach: I would be cautious to ask to ensure the project in question is not an issue. Red flags in this case are if the publication process is in limbo or significantly delayed, if funding has ceased, or if the PI plans to change roles/jobs.)

Cast a wide net and email attendings whose research you find interesting and ask if there is any way to get involved. Some of your requests will be ignored (don’t take it personally, people are just busy!) but by and large, academics are helpful and even if they don’t have a project that matches your interests, they will likely have a colleague to direct you to. 

So, whether you are interested in starting a project or joining an existing one, start drafting your emails. After all, what do you have to lose? 

Choosing a Research Opportunity

Pick an activity that aligns with your goals.

Naturally, you want to ensure the research activity you participate in aligns with your goals because, ultimately when you interview for residency or an introductory consulting position, or for a job in biotech, having a coherent theme in your publications that position alongside your passions will distinguish you amongst your peers.

Find a good fit with your PI

To get started on a research project, you will first need to find a mentor or principal investigator (PI). Criteria vary but generally, most agree that a good PI is:

  • 1. Prolific: They have had various publications over the past decade with academic peer-reviewed journals.
  • 2. Responsive: They do not take weeks to answer emails or are not away from their lab for weeks at a time.
  • 3. Has aligned interests: Publication takes a lot of work, often involving potentially hundreds of hours of effort. Thus, you and your PI should see it as a big deal. Make sure it is something you are interested in and advances your career whether you’re in a lab doing cell cultures or editing epidemiology papers or designing bio wearables at the intersection of healthcare and technology.
  • 4. Has adequate funding: This ensures you can be compensated, or at the very least your project has the funding necessary to move forward. Publishing in top-tier academic journals isn’t cheap!

Keep in mind that some residencies have research time built in, often in the form of research electives that can last months to a year. If your desired program allows, and you remain interested in research, share your research interests and projects to see if it can be continued at the institution, or if there is something in a similar realm. 

Decide which type of research project you’d like to pursue

The following are different types of medical research you could pursue as a medical student. This is not a comprehensive list, but rather, a starting point for where to look and how to increase your research output:

Image Source: NIH

Option #1: Case Reports and Series

A case report is a detailed write-up about the clinical course of a particular patient —an interesting presentation, an unusual case, a new potential treatment. It is used to describe an unusual or novel occurrence based on disease process, diagnosis, and/or treatment.  

Pay attention when you are on rotations if you see anything interesting or unusual. Do a quick PubMed search to see what’s already out there and if there isn’t much, take the initiative and ask your attending to write it.   

Case series, on the other hand, look at multiple patients in a retrospective manner. Case series are more tedious to write but also look better on an application as they provide more significant scientific conclusions. 

  • – Easy to write
  • – Least time-consuming 
  • – No funding needed
  • – Quick to publish if yours is accepted 
  • – Usually the least intensive data mining
  • – Not as impressive (thus easier to write and fast to publish)  
  • – Journals receive so many so it can be difficult to publish

Option #2: Clinical Research

This is the cream of the crop, the nitty gritty evidence-based medical research. Typically this includes the studies and trials you read about for the biostats portion of your exams. Anything from randomized trials to case-controlled trials and cohort studies are included in this broad category. 

  • – Highly regarded on applications  
  • – AOA offers students funding for certain research projects
  • – Significant contribution to medicine/science in your field 
  • – Publication includes more prestigious journals 
  • – Many barriers of entry (time, funding, depth of research)
  • – Requires IRB review meaning strict protocols 
  • – Requires large sample sizes, thus requiring dedicated time and often funding. 
  • – Students often use a dedicated research year to gain experience in this area.
  • – Slow and grueling publication process and peer review 

Option #3: Literature/Chart Review

Systematic literature or chart reviews basically existing work on a particular, unresolved, or controversial topic in medicine. There are different categories including meta-analyses, systematic reviews, and traditional literature reviews. 

This type of research typically involves combing through dozens to hundreds of charts in search of information that is relevant to the research question you are asking (i.e., scouring through charts for patients with multiple myeloma that were treated with a particular therapy and looking at the outcomes). Programs like Zotero can be helpful to make your searches easier. 

Furthermore, research librarians can be extremely helpful in using search tools, formatting your research, and going about the systematic review process in general. I highly recommend you reach out to your school librarian before you dive in as they are often a high-yield resource. 

  • – Accessible for students
  • – Meta-analysis and systematic reviews offer higher value and are more renowned
  • – Can often be done in remote collaboration 
  • – Flexible hours of work 
  • – Time-consuming to review 
  • – You will need access to various journals to be reviewed
  • – Tedious and repetitive work that is heavy in data analysis 
  • – Highly specialized! A sk your attendings for topic ideas as they will have a better sense of what is relevant in the field and what has the best chance of publication

What to Do After Publishing Your Research

You put in the effort, now it’s time to reap the rewards! While your friends or parents might not take note that you’re a footnote in this publication in NEJM, resident programs are sure to find out.  

On ERAS, there are separate sections for presentations and publications —one dropdown for papers that have already been published, and one for papers that have been submitted/accepted/in press. These appear separately on ERAS, so it’s ideal to have more in the “published” section, preferably in journals that are within your field. The topics look something like this: 

  • – Peer-Reviewed Journal Articles/Abstracts
  • – Peer-Reviewed Journal Articles/Abstracts (Other than Published = Submitted/Accepted)
  • – Peer-Reviewed Book Chapter
  • – Scientific Monograph
  • – Poster Presentation
  • – Oral Presentation
  • – Peer-Reviewed Online Publication
  • – Non-Peer-Reviewed Online Publication

6 Tips for Medical Students Getting Involved in Research

  • 1. Realize that research can be a very slow process. Even prestigious journals can hold on to submissions for months before ultimately making the decision to publish. 
  • 2. We are not cavemen, use tools! Web and citation tools such as Medeley and Connected Papers are free to use and help a great deal when it comes to tracking literature. 
  • 3. Formatting is important. Always read the instructions for authors on the websites of the journals you are submitting to. Each journal will have different, often strict specifications from the formatting and scientific writing standards to citation guidelines. The process between submission and publication will be a lot smoother if you follow the instructions ahead of time to avoid the back and forth before going to peer review.
  • 4. Writing is a team effort. Be sure to consult your teammates and definitely notify your PI if you have a concern or are unsure about some data.  
  • 5. You can only submit a particular paper to one journal at a time. Don’t submit the same paper to multiple journals at the same time. 
  • 6. Lastly, there have been increasing reports of predatory publishing scams. Always use protection and avoid these by first verifying publications that exist on legitimate databases such as PubMed. Stay safe!

Overall, the process of publishing research can be very frustrating, but also very rewarding, especially if you are genuinely interested in research or the topic. Remember to invest time to understand the demands before committing to the project. 

Discuss with the principal investigator what you want out of the project and be clear about your time commitment and intentions. Ask classmates for help and pass the word on to others. If you need it, take some extra time for your research. Good luck!

About the Author

Mike is a driven tutor and supportive advisor. He received his MD from Baylor College of Medicine and then stayed for residency. He has recently taken a faculty position at Baylor because of his love for teaching. Mike’s philosophy is to elevate his students to their full potential with excellent exam scores, and successful interviews at top-tier programs. He holds the belief that you learn best from those close to you in training. Dr. Ren is passionate about his role as a mentor and has taught for much of his life – as an SAT tutor in high school, then as an MCAT instructor for the Princeton Review. At Baylor, he has held review courses for the FM shelf and board exams as Chief Resident.   For years, Dr. Ren has worked closely with the office of student affairs and has experience as an admissions advisor. He has mentored numerous students entering medical and residency and keeps in touch with many of them today as they embark on their road to aspiring physicians. His supportiveness and approachability put his students at ease and provide a safe learning environment where questions and conversation flow. For exam prep, Mike will help you develop critical reasoning skills and as an advisor he will hone your interview skills with insider knowledge to commonly asked admissions questions.

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Top 10 Tips: Getting into Research as a Medical Student

Introducing our new series: Top 10 Tips – a simple guide to help you achieve your goals!

In this blog post, Jessica Xie (final year UCL medical student) shares advice on getting into research as a medical student.

how to start a medical research project

Disclaimers: 

  • Research is not a mandatory for career progression, nor is it required to demonstrate your interest in medicine. 
  • You can dip into and out of research throughout your medical career. Do not feel that you must continue to take on new projects once you have started; saying “no, thank you” to project opportunities will allow you to focus your energy and time on things in life that you are more passionate about for a more rewarding experience.
  • Do not take on more work than you are capable of managing. Studying medicine is already a full-time job! It’s physically and mentally draining. Any research that you get involved with is an extracurricular interest.

how to start a medical research project

I decided to write this post because, as a pre-clinical medical student, I thought that research only involved wet lab work (i.e pipetting substances into test tubes). However, upon undertaking an intercalated Bachelor of Science (iBSc) in Primary Health Care, I discovered that there are so many different types of research! And academic medicine became a whole lot more exciting…

Here are my Top 10 Tips on what to do if you’re a little unsure about what research is and how to get into it:

TIP 1: DO YOUR RESEARCH (before getting into research)

There are three questions that I think you should ask yourself:

  • What are my research interests?

Examples include a clinical specialty, medical education, public health, global health, technology… the list is endless. Not sure? That’s okay too! The great thing about research is that it allows deeper exploration of an area of Medicine (or an entirely different field) to allow you to see if it interests you.

2.  What type of research project do I want to do?

Research evaluates practice or compares alternative practices to contribute to, lend further support to or fill in a gap in the existing literature.

There are many different types of research – something that I didn’t fully grasp until my iBSc year. There is primary research, which involves data collection, and secondary research, which involves using existing data to conduct further research or draw comparisons between the data (e.g. a meta-analysis of randomised control trials). Studies are either observational (non-interventional) (e.g. case-control, cross-sectional) or interventional (e.g. randomised control trial).

An audit is a way of finding out if current practice is best practice and follows guidelines. It identifies areas of clinical practice could be improved.

how to start a medical research project

Another important thing to consider is: how much time do I have? Developing the skills required to lead a project from writing the study protocol to submitting a manuscript for publication can take months or even years. Whereas, contributing to a pre-planned or existing project by collecting or analysing data is less time-consuming. I’ll explain how you can find such projects below.

3.  What do I want to gain from this experience?

Do you want to gain a specific skill? Mentorship? An overview of academic publishing? Or perhaps to build a research network?

After conducting a qualitative interview study for my iBSc project, I applied for an internship because I wanted to gain quantitative research skills. I ended up leading a cross-sectional questionnaire study that combined my two research interests: medical education and nutrition. I sought mentorship from an experienced statistician, who taught me how to use SPSS statistics to analyse and present the data.

Aside from specific research skills, don’t forget that you will develop valuable transferable skills along the way, including time-management, organisation, communication and academic writing! 

TIP 2: BE PROACTIVE

Clinicians and lecturers are often very happy for medical students to contribute to their research projects. After a particularly interesting lecture/ tutorial, ward round or clinic, ask the tutor or doctors if they have any projects that you could help them with! 

TIP 3: NETWORKING = MAKING YOUR OWN LUCK

Sometimes the key to getting to places is not what you know, but who you know. We can learn a lot from talking to peers and senior colleagues. Attending hospital grand rounds and conferences are a great way to meet people who share common interests with you but different experiences. I once attended a conference in Manchester where I didn’t know anybody. I befriended a GP, who then gave me tips on how to improve my poster presentation. He shared with me his experience of the National institute of Health Research (NIHR) Integrated Academic Training Pathway and motivated me to continue contributing to medical education alongside my studies.

TIP 4: UTILISE SOCIAL MEDIA

Research opportunities, talks and workshops are advertised on social media in abundance. Here are some examples:

Search “medical student research” or “medsoc research” into Facebook and lots of groups and pages will pop up, including UCL MedSoc Research and Academic Medicine (there is a  Research Mentoring Scheme Mentee Scheme), NSAMR – National Student Association of Medical Research and International Opportunities for Medical Students .

Search #MedTwitter and #AcademicTwitter to keep up to date with ground-breaking research. The memes are pretty good too.

Opportunities are harder to come by on LinkedIn, since fewer medical professionals use this platform. However, you can look at peoples’ resumes as a source of inspiration. This is useful to understand the experiences that they have had in order to get to where they are today. You could always reach out to people and companies/ organisations for more information and advice.

TIP 5: JOIN A PRE-PLANNED RESEARCH PROJECT

Researchers advertise research opportunities on websites and via societies and organisations such as https://www.remarxs.com and http://acamedics.org/Default.aspx . 

TIP 6: JOIN A RESEARCH COLLABORATIVE

Research collaboratives are multiprofessional groups that work towards a common research goal. These projects can result in publications and conference presentations. However, more importantly, this is a chance to establish excellent working relationships with like-minded individuals.

Watch out for opportunities posted on Student Training and Research Collaborative .

Interested in academic surgery? Consider joining StarSurg , BURST Urology , Project Cutting Edge or Academic Surgical Collaborative .

Got a thing for global health? Consider joining Polygeia . 

TIP 7: THE iBSc YEAR: A STEPPING STONE INTO RESEARCH

At UCL you will complete an iBSc in third year. This is often students’ first taste of being involved in research and practicing academic writing – it was for me. The first-ever project that I was involved in was coding data for a systematic review. One of the Clinical Teaching Fellows ended the tutorial by asking if any students would be interested in helping with a research project. I didn’t really know much about research at that point and was curious to learn, so I offered to help. Although no outputs were generated from that project, I gained an understanding of how to conduct a systematic review, why the work that I was contributing to was important, and I learnt a thing or two about neonatal conditions. 

TIP 8: VENTURE INTO ACADEMIC PUBLISHING

One of the best ways to get a flavour of research is to become involved in academic publishing. There are several ways in which you could do this:

Become a peer reviewer. This role involves reading manuscripts (papers) that have been submitted to journals and providing feedback and constructive criticism. Most journals will provide you with training or a guide to follow when you write your review. This will help you develop skills in critical appraisal and how to write an academic paper or poster. Here are a few journals which you can apply to:

  • https://thebsdj.cardiffuniversitypress.org
  • Journal of the National Student Association of Medical Researchjournal.nsamr.ac.uk
  • https://cambridgemedicine.org/about  
  • https://www.bmj.com/about-bmj/resources-reviewers  

Join a journal editorial board/ committee. This is a great opportunity to gain insight into how a medical journal is run and learn how to get published. The roles available depend on the journal, from Editor-in-Chief to finance and operations and marketing. I am currently undertaking a Social Media Fellowship at BJGP Open, and I came across the opportunity on Twitter! Here are a few examples of positions to apply for:

  • Journal of the National Student Association of Medical Researchjournal.nsamr.ac.uk – various positions in journalism, education and website management
  • https://nsamr.ac.uk – apply for a position on the executive committee or as a local ambassador
  • Student BMJ Clegg Scholarship
  • BJGP Open Fellowships

TIP 9: GAIN EXPERIENCE IN QUALITY IMPROVEMENT

UCL Be the Change is a student-led initiative that allows students to lead and contribute to bespoke QIPs. You will develop these skills further when you conduct QIPs as part of your year 6 GP placement and as a foundation year doctor.

TIP 10: CONSIDER BECOMING A STUDENT REPRESENTATIVE

You’ll gain insight into undergraduate medical education as your role will involve gathering students’ feedback on teaching, identifying areas of curriculum that could be improved and working with the faculty and other student representatives to come up with solutions. 

It may not seem like there are any research opportunities up for grabs, but that’s where lateral thinking comes into play: the discussions that you have with your peers and staff could be a source of inspiration for a potential medical education research project. For example, I identified that, although we have lectures in nutrition science and public health nutrition, there was limited clinically-relevant nutrition teaching on the curriculum. I then conducted a learning needs assessment and contributed to developing the novel Nutrition in General Practice Day course in year 5.

Thanks for reaching the end of this post! I hope my Top 10 Tips are useful. Remember, research experience isn’t essential to become a great doctor, but rather an opportunity to explore a topic of interest further.

One thought on “Top 10 Tips: Getting into Research as a Medical Student”

This article was extremely helpful! Alothough, I’m only a junior in high school I have a few questions. First, is there anyway to prepare myself mentally for this challenging road to becoming a doctor? check our PACIFIC best medical college in Rajasthan

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How to Get Started With a Research Project

Last Updated: October 3, 2023 Fact Checked

This article was co-authored by Chris Hadley, PhD . Chris Hadley, PhD is part of the wikiHow team and works on content strategy and data and analytics. Chris Hadley earned his PhD in Cognitive Psychology from UCLA in 2006. Chris' academic research has been published in numerous scientific journals. This article has been fact-checked, ensuring the accuracy of any cited facts and confirming the authority of its sources. This article has been viewed 310,565 times.

You'll be required to undertake and complete research projects throughout your academic career and even, in many cases, as a member of the workforce. Don't worry if you feel stuck or intimidated by the idea of a research project, with care and dedication, you can get the project done well before the deadline!

Development and Foundation

Step 1 Brainstorm an idea or identify a problem or question.

  • Don't hesitate while writing down ideas. You'll end up with some mental noise on the paper – silly or nonsensical phrases that your brain just pushes out. That's fine. Think of it as sweeping the cobwebs out of your attic. After a minute or two, better ideas will begin to form (and you might have a nice little laugh at your own expense in the meantime).

Step 2 Use the tools you've already been given.

  • Some instructors will even provide samples of previously successful topics if you ask for them. Just be careful that you don't end up stuck with an idea you want to do, but are afraid to do because you know someone else did it before.

Step 4 Think from all angles.

  • For example, if your research topic is “urban poverty,” you could look at that topic across ethnic or sexual lines, but you could also look into corporate wages, minimum wage laws, the cost of medical benefits, the loss of unskilled jobs in the urban core, and on and on. You could also try comparing and contrasting urban poverty with suburban or rural poverty, and examine things that might be different about both areas, such as diet and exercise levels, or air pollution.

Step 5 Synthesize specific topics.

  • Think in terms of questions you want answered. A good research project should collect information for the purpose of answering (or at least attempting to answer) a question. As you review and interconnect topics, you'll think of questions that don't seem to have clear answers yet. These questions are your research topics.

Step 7 Brush across information you have access to.

  • Don't limit yourself to libraries and online databases. Think in terms of outside resources as well: primary sources, government agencies, even educational TV programs. If you want to know about differences in animal population between public land and an Indian reservation, call the reservation and see if you can speak to their department of fish and wildlife.
  • If you're planning to go ahead with original research, that's great – but those techniques aren't covered in this article. Instead, speak with qualified advisors and work with them to set up a thorough, controlled, repeatable process for gathering information.

Step 8 Clearly define your project.

  • If your plan comes down to “researching the topic,” and there aren't any more specific things you can say about it, write down the types of sources you plan to use instead: books (library or private?), magazines (which ones?), interviews, and so on. Your preliminary research should have given you a solid idea of where to begin.

Expanding Your Idea with Research

Step 1 Start with the basics.

  • It's generally considered more convincing to source one item from three different authors who all agree on it than it is to rely too heavily on one book. Go for quantity at least as much as quality. Be sure to check citations, endnotes, and bibliographies to get more potential sources (and see whether or not all your authors are just quoting the same, older author).
  • Writing down your sources and any other relevant details (such as context) around your pieces of information right now will save you lots of trouble in the future.

Step 2 Move outward.

  • Use many different queries to get the database results you want. If one phrasing or a particular set of words doesn't yield useful results, try rephrasing it or using synonymous terms. Online academic databases tend to be dumber than the sum of their parts, so you'll have to use tangentially related terms and inventive language to get all the results you want.

Step 3 Gather unusual sources.

  • If it's sensible, consider heading out into the field and speaking to ordinary people for their opinions. This isn't always appropriate (or welcomed) in a research project, but in some cases, it can provide you with some excellent perspective for your research.
  • Review cultural artifacts as well. In many areas of study, there's useful information on attitudes, hopes, and/or concerns of people in a particular time and place contained within the art, music, and writing they produced. One has only to look at the woodblock prints of the later German Expressionists, for example, to understand that they lived in a world they felt was often dark, grotesque, and hopeless. Song lyrics and poetry can likewise express strong popular attitudes.

Step 4 Review and trim.

Expert Q&A

Chris Hadley, PhD

  • Start early. The foundation of a great research project is the research, which takes time and patience to gather even if you aren't performing any original research of your own. Set aside time for it whenever you can, at least until your initial gathering phase is complete. Past that point, the project should practically come together on its own. Thanks Helpful 1 Not Helpful 0
  • When in doubt, write more, rather than less. It's easier to pare down and reorganize an overabundance of information than it is to puff up a flimsy core of facts and anecdotes. Thanks Helpful 1 Not Helpful 0

how to start a medical research project

  • Respect the wishes of others. Unless you're a research journalist, it's vital that you yield to the wishes and requests of others before engaging in original research, even if it's technically ethical. Many older American Indians, for instance, harbor a great deal of cultural resentment towards social scientists who visit reservations for research, even those invited by tribal governments for important reasons such as language revitalization. Always tread softly whenever you're out of your element, and only work with those who want to work with you. Thanks Helpful 8 Not Helpful 2
  • Be mindful of ethical concerns. Especially if you plan to use original research, there are very stringent ethical guidelines that must be followed for any credible academic body to accept it. Speak to an advisor (such as a professor) about what you plan to do and what steps you should take to verify that it will be ethical. Thanks Helpful 6 Not Helpful 2

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  • ↑ http://www.butte.edu/departments/cas/tipsheets/research/research_paper.html
  • ↑ https://www.nhcc.edu/academics/library/doing-library-research/basic-steps-research-process
  • ↑ https://library.sacredheart.edu/c.php?g=29803&p=185905
  • ↑ https://owl.purdue.edu/owl/general_writing/common_writing_assignments/research_papers/choosing_a_topic.html
  • ↑ https://www.unr.edu/writing-speaking-center/student-resources/writing-speaking-resources/using-an-interview-in-a-research-paper
  • ↑ https://www.science.org/content/article/how-review-paper

About This Article

Chris Hadley, PhD

The easiest way to get started with a research project is to use your notes and other materials to come up with topics that interest you. Research your favorite topic to see if it can be developed, and then refine it into a research question. Begin thoroughly researching, and collect notes and sources. To learn more about finding reliable and helpful sources while you're researching, continue reading! Did this summary help you? Yes No

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How to Conduct Research During Medical School

Researching

Table of Contents

Most med schools in the United States require that you participate in some sort of scholarly project. Participation in the academic life of medicine is a great way to enhance your residency applications, and it may even be expected or required to successfully match in the most competitive specialties.

Traditionally, medical student research took the shape of a formal research opportunity in a research lab with a research mentor, culminating in a publication. Today, research in medical school takes a variety of forms, including the traditional one.

Beyond the typical lab format, medical students engage in scholarship by conducting poster presentations, writing up case presentations of interesting diseases they have encountered on the wards, or participating in quality improvement initiatives or other health systems science projects. All of these scholarly pursuits fall under the broad category of “research”, which may be required during medical school, and all contribute to the strength of a student’s residency application. 

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Is It Even Possible to Do Research in Medical School? 

With all the day-to-day challenges of medical school, it can be difficult to see where time for research fits in. With good planning and time management, however, you can include research in medical school. While fulfilling your clerkship requirements, studying and passing exams and courses, and taking care of patients are all top priorities, carving out time for research is certainly a possibility, especially on lighter rotations and with the udicious use of elective time. 

Many medical schools now offer a dedicated research period for you to engage in scholarship. Depending on the project, this period may be more or less time than you need to complete your research. You should check to see if your school offers dedicated time for research, and when it is.If you do have a dedicated research block, checking with your school about the expectations for deliverables at the end of the time period, as well as whether the block is structured or unstructured, will help you to make the most of this block.

If your school does not offer a specific time period for research and you anticipate needing to work on a project full-time, using elective time for research or scheduling research during lighter rotations can be a great way to make the time you need for research. 

When is the best time to do research in medical school? 

For many medical students, especially those applying to highly competitive specialties, you’ll want to start thinking about when to do research in medical school early in your academic career. If you know you have specific research or subspecialty interest going into medical school, start looking for a research project or mentor as soonas possible. This will maximize your chances of completing published research by the time you need to apply for a residency program.

If you are not sure about research or aren’t interested in conducting research at all, waiting until closer to your residency application and choosing an interesting case or project to present as a case conference or poster may make more sense. If you do intend to publish a paper or complete a large scholarly project, make sure you start early so that your project is complete in time for residency applications, recognizing that not every project results in a publication. For larger projects, it makes sense to have identified a research mentor and to start working on your project sometime before the beginning of your second year.

Keep in mind that the publication process of peer review and article revisions can take longer than anticipated, and your article may not appear in print until several months after you submit your abstract.

Smaller projects, such as a case vignette or poster presentation, typically have a much faster turnaround time – usually only a few months from project inception to presentation, depending on the venue where you present. 

Do you have to do research in medical school?

Even for physicians in training who have no desire to do research after medical school, research can be a useful way to build skills that will be helpful in their future career. For instance, a student interested in hospital medicine might use the research time to complete a quality improvement project on reducing the risk of infections acquired in a hospital, which in turn might help them in a future role as a medical director.

A future general surgeon might decide to use the research time to get an MBA, helping them gain the business skills necessary to run a successful independent practice. A prospective infectious disease specialist might conduct a public health study that gets them comfortable with interpreting statistics, which could be beneficial when running a local health department.

Students who are not interested in staying in academics after graduation but are required to do research should make use of dedicated research time to build skills that they can apply outside of the academic world. 

How to Do Research as a Medical Student

Every good research project starts with a question. You’re far more likely to stay engaged in research, and to produce a good research product, if you have a real interest in the question your project aims to answer. Once you’ve identified a question you hope to answer, ask your professors, attending physicians, and even other classmates if they know of anyone working on a similar question.

While you might not identify someone working on exactly what you are interested in, you’ll likely find someone with similar interests who can direct you to someone who is well-aligned with your interests. Once you identify a research mentor, it’s up to you to determine what your goals are in doing research.

If you intend to publish a paper that appears in a top-notch medical journal, for instance, your research will probably require more time and effort than if you hope to do a case presentation of an interesting disease you encountered on rounds.

Try to tailor the scope of your project to the time you have available to complete it. “I want to cure cancer” is not a realistic goal for a research project to complete as a medical student, but working on a specific gene pathway with a goal of presenting a poster at a national conference might be! 

How to find research opportunities

Finding research opportunities as a medical student starts with identifying your area of interest. Do you have a subspecialty you are particularly fascinated by? If so, reaching out to an academic specialist in your area of interest is a great first step to finding research opportunities.

Fascinated by a particular case you saw on rounds? Ask your attending physician if they think the case might be appropriate for a poster presentation or to present at an academic conference. Not interested in writing up case reports or writing long research abstracts? Maybe an opportunity in quality improvement is right for you – ask your attending physicians if there are any hospital-level projects or initiatives which could benefit from some help.

Do you have a specific idea that you think could change the world? Try applying for a research grant or scholarship to help fund that opportunity and make it a reality. In many medical schools, and especially in those associated with academic research centers, the only limitations on research opportunities are those of your own imagination! 

How is medical research funded?

Most medical research projects conducted by medical students are not funded and occur on the side, with a student volunteering their time and effort toward a project. However, if you are planning on a more extensive project that would take you away from your normal studies for a year or more, there are a variety of foundations and funded research opportunities that you can use to support yourself during the time you are conducting your research.

Generally speaking, the best opportunity to engage in funded medical research is by enrolling in a combined MD/PhD program.

If you are interested in a specific field of study and want to have protected, dedicated time to engage in medical research prior to residency, a combined MD/PhD program will give you the best balance of clinical and research training. However, MD/PhD programs are highly selective and are not available at every medical school.

You can learn more about combined degree programs on the AAMC website . The American Physician Scientists Association also maintains a list of funding opportunities for MD/PhD candidates on their website.  

To Sum It Up…

Spending some time engaging in research during medical school can be rewarding, both personally and professionally. Although opportunities to engage in traditional research abound in medical school, students who are not interested in this can explore alternatives to traditional research, like case presentations, quality improvement projects, or even dual degree programs like an MBA. Pursuing research in any of these forms can be a great way to improve your residency application and help you develop the skills you need to succeed long after medical school.

Brennan Kruszewski

Dr. Brennan Kruszewski is a practicing internist and primary care physician in Beachwood, Ohio. He graduated from Emory University School of Medicine in 2018, and recently completed his residency in Internal Medicine at University Hospitals/Case Western Reserve University in Cleveland. He enjoys writing about a variety of medical topics, including his time in academic medicine and how to succeed as a young physician. In his spare time, he is an avid cyclist, lover of classical literature, and choral singer.

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Starting a Career in Medical Device Development

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Medical device development is the process of creating a functional medical device, from the inspiration phase to the post-market surveillance phase. Medical devices are used in all aspects of patient care, improving peoples’ lives and lowering healthcare costs. 1

The thriving medical device industry is expected to reach $595 million in 2024, offering many job opportunities for new engineers. 2 The rapid advancements of artificial intelligence, combined with the growth in recent years of digital therapeutics and biometric wearable technology, make this an exciting time to start a career in this dynamic business.

This post offers considerations for starting a career in medical device development, including the necessary education and skills, as well as possible career paths.

Emerging Technologies in Medical Device Development

Driven by an increasing emphasis on patient-centered care, medical device technologies are making a positive impact on healthcare delivery by facilitating effective, efficient and personalized care. Devices that are programmed with artificial intelligence and machine learning capabilities, for example, can tailor medical care to a patient’s health history data. Not all patients respond the same way to medicines and treatments. Medical devices can provide personalized care by tracking a patient’s responses so each treatment plan can be adjusted as necessary. 3

In robot-assisted noninvasive surgery, systems such as the da Vinci Surgical System and the ROSA Spine robotic surgical assistant provide a less-invasive alternative to traditional surgery. Doctors can use them to operate with greater precision and reduce the cost, recovery time and complications of surgery. 3

Educational Pathways and Qualifications

The development of a medical device is a highly technical process that draws on knowledge of engineering, technology and science. A bachelor’s degree that demonstrates high-level skills in medical science and engineering, such as a biomedical engineering degree, is the minimum requirement most companies look for when hiring. 4

However, a master's degree in biomedical engineering will open up even more doors to an upper-level career. With an advanced degree, you can pursue more research and supervisory opportunities. 4 A professional license such as the Professional Licensed Engineer (PE) credential will also demonstrate your commitment to the field and give you a competitive advantage over other candidates.

In conjunction with your formal education, a medical engineering internship can also offer the opportunity to learn from seasoned professionals in a real-world setting. You’ll gain hands-on experience and make connections that will be valuable to your career and instrumental in your success. 4

Essential Skills for Medical Device Developers

This multi-disciplinary and dynamic career path requires a broad range of skills, from the technical to the creative. You’ll need a firm grounding in engineering principles and methods in order to iterate through the designing, prototyping, testing and optimizing phases. You'll also need a deep understanding of medical science and tools and technologies such as Python, CAD and MATLAB. 5

Beyond the technical basics, medical device developers also have to understand regulatory compliance, as medical devices are subject to many industry standards and laws. The process of developing new or improved medical devices also requires creativity and problem-solving skills, as well as strong teamwork, collaboration and communication and a commitment to lifelong learning. 5

Career Possibilities

Medical device developers can work in various jobs in biomedical engineering. Some have targeted responsibilities, working on one aspect of a device or process, while others work in broader roles that include all phases of development. Career prospects in medical device design include the following:

Systems Engineer

Systems engineers design, develop and test systems related to medical devices to ensure they’re effective, efficient and compliant with all applicable regulations. They work with vendors, clients and suppliers, so they need good technical and communication abilities, including critical thinking and knowledge of risk management, data architecture and information security. 6

Project Manager

Project managers are responsible for directing and overseeing all aspects of medical device development. They create plans that include budgets, timelines, staffing and client communication. Because they have to balance so many different priorities and responsibilities within a team of professionals, they need strong communication, time management and organizational proficiency. 6

Product Development Engineer

Product development engineers design or improve medical devices by drawing on a strong understanding of industry trends , patient needs and technological design. They create, prototype and test devices to achieve an optimal user experience. 6

Bioprocess Engineer

Bioprocess engineers contribute to developing medical devices through their understanding of how cells and other biological organisms function. Their expertise helps create medical devices that achieve optimal health results, such as efficient delivery of chemotherapy agents. 7

Research Engineer

Research engineers collect and analyze data to help medical device stakeholders make informed decisions about product development. Their responsibilities include investigating, modeling, testing and verifying research that could impact a device’s performance in clinical trials and real-world settings. This role demands superior analytical, critical-thinking, technical and communication skills. 6

Ethical Considerations in Device Development

As with all aspects of healthcare, medical devices hold the potential not only to improve patient health and outcomes, but also to exacerbate risks and pose new threats. Unfortunately, devices often have a lower standard of evidence than other medical therapies, which has led to the approval of some devices, such as metal-on-metal hips and vaginal mesh, that were later found to be harmful. 8

The integration of software in medical devices, such as pacemakers and insulin pumps, also presents new challenges. These include frequent updates affecting device functionality, cybersecurity risks and ethical concerns about the misuse of collected physiological data. 6 Similarly, increased customization, especially through technologies like 3D printing, has the potential to transform healthcare but poses challenges for obtaining rigorous evidence of safety and effectiveness. Customized devices may bypass traditional regulatory controls, raising new risks. 8

Moving forward, the industry may need to develop a new approach based on reasoned assessment and defensible ethical decisions, especially in the face of advancing technologies such as generative AI and machine learning. 8

Advance Your Medical Device Design Career

Case Western Reserve University’s online MS in Biomedical Engineering program will prepare you for leadership and success in the field of medical device development. Our faculty members regularly engage in cutting-edge research and bring their deep expertise and enthusiasm to their classes. Learn on your own schedule in this entirely online program . Expand your professional network and build the foundation you need to stand out from the crowd in a dynamic, growing industry.

To learn more, schedule a call with one of our admissions outreach advisors today.

  • Retrieved on December 26, 2023, from medium.com/@drjonkiev/the-impact-of-medical-devices-on-healthcare-costs-a-comprehensive-analysis-9de82e4d996
  • Retrieved on December 26, 2023, from alpha-sense.com/blog/trends/medical-device-trends-outlook/
  • Retrieved on December 26, 2023, from luxoft.com/blog/technology-trends-and-the-future-of-medical-devices
  • Retrieved on December 26, 2023, from indeed.com/career-advice/finding-a-job/how-to-become-medical-engineer
  • Retrieved on December 26, 2023, from linkedin.com/advice/3/what-essential-skills-medical-device-product-e0xve
  • Retrieved on December 26, 2023, from joinhandshake.com/blog/students/biomedical-engineering-jobs/
  • Retrieved on December 26, 2023, from indeed.com/career-advice/finding-a-job/what-is-bioprocess-engineering
  • Retrieved on December 26, 2023, from healthvoices.org.au/issues/november-2017/ethics-advanced-medical-devices-need-new-approach/

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How to Choose and Prioritize Extracurricular Activities as a Premed Student

Engage in activities that reflect your passion and commitment to serving others, and choose quality over quantity.

Premeds and Extracurricular Activities

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Extracurriculars are a great way explore what kind of field you want to go into.

Extracurricular activities can help to differentiate your application in the medical school admissions process and require thoughtful decision-making and careful planning.

Here's some advice on choosing and prioritizing extracurriculars, plus some examples of activities that may impress med school admissions officers.

Identify and Understand Your Career Goals 

The best extracurricular activities will be personally tailored to your specific goals in medicine and in your career. It is essential to align extracurriculars with your goals, so dedicate some time to reflecting on your personal interests, values and career aspirations. Work to identify areas of genuine passion . Try not to bend to outside pressures or negative comparisons with other premedical students, but instead pursue opportunities that excite you. 

For example, if you have no interest in research but a proclivity for service and volunteering, pursue those activities at the expense of joining a laboratory. If you feel particularly excited by a medical or surgical subfield, it is never too early to get involved in specialty-specific interests, such as clinical volunteering in an emergency department or dialysis unit, as a sitter in a psychiatry department, etc. 

A great way to gain exposure to a specific field, and validate your early interest, is by joining a clinical research laboratory. Many clinical labs and trials are run by practicing clinicians. Select ones in your area of interest and ask for opportunities to contribute.

You will likely dedicate significant time to two or three extracurricular activities as an undergraduate premed student, so be sure they align with your actual interests. 

Carefully Select and Manage Commitments to Extracurricular Activities 

Assess your personal time constraints and prior commitments. When you know you have available time, reach out to several possible opportunities, such as clinical work, service, basic or translational research projects, or leadership activities. Don’t be shy – cold email to get your foot in the door! 

Start a single extracurricular activity at first, and verify that you can balance your academics and personal life before you take on more responsibilities. It can reflect poorly if you back out of a commitment soon after it was made, so begin only activities you know you can commit to.

Admissions committees value significant, longitudinal time investments in a single activity more than brief involvement in many extracurriculars, and you will find sticking with activities more personally rewarding in the long term, as well. 

Don’t underestimate the time required to meaningfully contribute to a research endeavor. Expect to commit significant time to lab work in order to gain meaningful skills or contribute to a project.

At the same time, if you enjoy the work, advocate for yourself to present an abstract, contribute to a publication or write an honors thesis. Purposeful involvement in any extracurricular activity will shine through in your application. 

Describe Your Extracurriculars With Purpose in Your Application 

When it comes time to apply to med school, spend significant time on the extracurricular activity descriptions. Describe explicitly and concisely what you did, but also craft a compelling narrative around your decision to pursue each activity. Highlight any personal growth that has come as a result, lessons you’ve learned and any impact you’ve been able to have on others.

Even if an activity is common, your experience is unique. Describe a unique clinical encounter you had, a memorable patient or mentee you helped or a service experience that changed the way you see your career. 

You did the legwork and spent many, many hours on a research project, volunteering in a free clinic or leading a tutoring program, so be sure to present these experiences thoughtfully. You want your application to read like a coherent and engaging story, and you want admissions committees to feel that they have gotten to know you through your decisions and experiences presented in your application. 

What Are Meaningful Extracurricular Activities? 

Many possible extracurricular activities can be meaningful on a medical school application. 

If clinical work interests you, working in a free clinic, volunteering in an ER or other hospital department, "sitting" in a psychiatric department or shadowing physicians in any specialty can be significant experiences. 

If you find yourself drawn to service, consider opportunities such as mentoring underprivileged youth, organizing preventative health care fairs in underserved communities and working in shelters or soup kitchens. 

Leadership opportunities can be less easy to find, but serving as president of a student organization, leading an initiative to address a health disparity or coordinating a team of volunteers are realistic examples of meaningful leadership experiences that can be attained before medical school. 

If you’re excited by the possibility of expanding your understanding of biology and medicine, then basic, clinical or translational research is a substantial activity readily available at most major academic centers and universities. The only limit is how much available time you have, as this is a significant investment.

Nonetheless, if research excites you, many faculty members are eager to have an enthusiastic undergraduate premed student join their laboratory. All you need to do is reach out.

Additional Tips for Success 

Engage in a diverse range of activities, if possible. Exploring different interests is an essential aspect of the undergraduate premed experience, and you may not know what interests you until you try.

Avoid subconsciously boxing yourself into a career plan too early, and don’t be afraid to take the leap and explore a new extracurricular activity. It is never too late to gain experience and discover a passion. 

Within extracurricular activities, seek out opportunities to showcase initiative and demonstrate leadership potential. The more you show that you can do, the more responsibilities you are likely to be given, and the more meaningful the experience will be to you and your application. 

Above all, pursue activities that align with your long-term career goals and personal values. While exploring new avenues is important and exciting, if you want to pursue a career centered on service , for example, try to build up significant experience in service-oriented extracurriculars so that you are prepared for such a career. The same goes for research, clinical subspecialty work, etc. 

Don’t force yourself to continue in an extracurricular activity you don’t enjoy, just because “everyone is doing research” or because of an existential need to “check the box." Your time is much too valuable to make decisions in this manner. Pursue opportunities that make you excited and will help prepare you for a career in medicine, and you will be well positioned to be a great medical school applicant. 

Thoughtfully select extracurricular activities that reflect genuine passion and commitment to serving others, focus on quality over quantity and describe your activities with purpose and thoughtfulness throughout your application. With hard work and commitment, you should be able to leverage extracurricular experiences to learn, expand your skill set and stand out in the medical school admissions process.

Medical School Application Mistakes

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About Medical School Admissions Doctor

Need a guide through the murky medical school admissions process? Medical School Admissions Doctor offers a roundup of expert and student voices in the field to guide prospective students in their pursuit of a medical education. The blog is currently authored by Dr. Ali Loftizadeh, Dr. Azadeh Salek and Zach Grimmett at Admissions Helpers , a provider of medical school application services; Dr. Renee Marinelli at MedSchoolCoach , a premed and med school admissions consultancy; Dr. Rachel Rizal, co-founder and CEO of the Cracking Med School Admissions consultancy; Dr. Cassie Kosarec at Varsity Tutors , an advertiser with U.S. News & World Report; Dr. Kathleen Franco, a med school emeritus professor and psychiatrist; and Liana Meffert, a fourth-year medical student at the University of Iowa's Carver College of Medicine and a writer for Admissions Helpers. Got a question? Email [email protected] .

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  • Clin Colon Rectal Surg
  • v.24(2); 2011 Jun

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Career Development

Getting started in clinical research, james w. fleshman, jr..

1 Section of Colon and Rectal Surgery, Washington University School of Medicine, St. Louis, Missouri

Clinical research is an important part of an academic surgery practice. To be successful, it is important to understand the multiple regularity committees and organizations that impact research. The author briefly reviews these groups and provides guidance on how to initiate and conduct research.

It is one of the great pleasures of academic surgery to be able to participate in clinical research. Most patients who come to the academic institution are willing to participate in meaningful studies that potentially could change the practice of medicine and improve outcomes for patients. As an academic surgeon, the privilege of taking care of patients involved in research is one of the highest benefits and honors that can be bestowed on a physician. My career at Washington University School of Medicine in St. Louis has provided me with such an honor and gift. Throughout my career, the focus of my research has transitioned from basic science to translational to clinical research. It is one of the most exciting things that I do on a daily basis and allows me to continually reevaluate the way I take care of patients, train residents, and relate to other medical care providers.

When starting clinical research, there are certain facts that are very important for the clinical research physician. I call this getting to know your “regulatory alphabet.” The Institutional Review Board (IRB) or the Human Studies Review Committee (HSRC) oversees the institutional clinical research. This body can be your friend or your worst nightmare depending on whether you follow the rules. The Human Research Protection Office (HRPO) audits and mandates professionalism within clinical research. This office is a governmental agency and uses the Office of the Inspector General (OIG) as its enforcement arm. OIG agents carry guns and badges and can bring criminal charges. The HRPO protects patients from fraud and improper clinical research and lends legitimacy to the clinical research being performed by academic institutions.

All clinical research must be in compliance with the Health Insurance Portability and Accountability Act (HIPAA). The legislative arm of the government has mandated that we should protect the confidential, sensitive information of each patient, even while performing clinical research. For this reason, HIPAA has set up guidelines which we follow to avoid identification of patients in publications and reports of the research.

Particular types of research provide their own institutional oversight. For example, if one practices in a comprehensive cancer center, the research is coordinated through the Peer Review Monitoring Committee (PRMC). This is a conflict prevention and management program by which researchers can discuss and review potential studies to limit overlap, prevent encroachment by a proposed study upon a patient population that is being used for an established study, and expose and resolve conflict between members of the clinical trials group.

Each institution requires that a Data Safety Monitoring Board (DSMB) audit the collected data for all intrainstitutional trials. These are trials that are investigator initiated and are not being monitored by outside groups, such as industry or government. The DSMB can close clinical research just as easily as the HRPO, IRB, and other groups already mentioned. It is important that the DSMB be involved to avoid such fiascos as have occurred in recent experience in the military; data falsified and outcomes invented to prove an investigator's point. Therefore, the DSMB prevents any question of the legitimacy of the data that is produced.

The Institutional Billing Matrix (IBM) has been established to eliminate fraud by clinical researchers receiving double payment on research patients. The institution must keep track of all patients who are involved in clinical trials. In some trials, the investigator is being reimbursed for diagnostic procedures. Most patients participating in industry or government led trials will have funds directed toward paying for some of their care. The institution billing matrix should alert the clinical researcher and hospital of the potential for double billing for patient care. This occasionally occurs without the clinical researcher's knowledge. Even so, the researcher is responsible for billing fraud, a criminal offense.

GETTING STARTED

First, identify a question and develop a hypothesis before designing a trial. This is most often observation driven, but now it may be driven by a new technology or the desire to evaluate comparative effectiveness.

Next, identify an appropriate study population. Basic science can answer some questions for clinical research; however, the majority of clinical research is performed on patients. The appropriate patient base is important. In some circumstances, such as new technology, the first step may be an animal study to provide safety and efficacy data prior to introduction into the patient population. The study population may not be patients. There is a role for studying the educational process in surgery within or after residency training programs or as it affects assimilation of new technology.

Finally, all clinical research should incorporate a control group for comparison. Retrospective or prospective series of patient events or outcomes are no longer adequate to establish a new intervention or change clinical practice. The control group can be current (as with randomized controlled trials) or consecutive, but not involved in the study directly (as with case-matched controlled trials). Historical controls are the least accurate method of establishing a control, and time has made them irrelevant because there are other confounding factors involved in their care, such as advances in new technology unrelated to the technology or the treatment being evaluated.

PRESTUDY STATISTICS

A power calculation is essential to determine the appropriate sample size for both a prospective comparison and a retrospective review comparison. This requires an estimation of the expected difference between two study groups or a study group and the control. The appropriate comparative statistical method can be used in a power calculation formula to determine the number of patients needed in the study. The sample size calculation is based on achieving significance ( P -value) given the predicted percent difference between the two groups at a desired power (percent level of confidence). This is available in most commercial statistical packages or through the biostatistics core of an academic institution.

Before starting a comparative trial, the untoward events (such as complications or unanticipated consequences) that would require study closure must be defined. “Stopping parameters” for new techniques or drugs prevent study completion with harm to a significant number of patients. This is obviously not needed for retrospective reviews.

It is helpful to design a study in collaboration with a statistician. Most institutions have a “central core” of biostatistics, which is available on a consultation basis. The participating statistician would be reimbursed for time spent or as a percentage of effort on the trial itself.

DATABASE STUDIES

One of the most basic forms of clinical research is the retrospective or prospective review of patients. It is important to design the database to be as comprehensive as possible; however, resources may restrict the ability to enter massive amounts of data to a comprehensive database. The estimated salary outlay for a database manager is approximately $35,000 per year for a full-time manager. It is possible to incorporate other functions into the database manager's job description, such as most institutions require design and production of clinical reports or troubleshooting for office computing needs.

Most institutions require IRB approval before the first patient is entered into a database. The IRB has now become the overall protector of all patient data being used in research, and databases are now scrutinized by the IRB and must be approved before beginning the first evaluation of a patient in a retrospective study.

Search and report packages should be built into the database. This gives the section or practice an update on patient volumes and patient diseases that can help design trials around specific questions. If the database manager is not capable of designing these packages, the researcher should consider contracting with the institution information systems to maintain, update, and backup the database and design the reports. A simple package of reports, as a start, can be eventually uploaded into a more sophisticated, analytic package for the future.

LEVEL OF EVIDENCE

The American Society of Colon and Rectal Surgeons (ASCRS) has designated different levels of evidence for use by its Practice Parameters Group. A “level of evidence” appropriate for writing a parameter may not be possible for a small clinical trial effort to achieve. As a researcher gains more experience, the “level of evidence” produced by the institution trial should improve. To establish a clinical trials mechanism in your own institution, the accompanying listing of levels of evidence may be most appropriate (refer to Table ​ Table1). 1 ). The highest level (I) of evidence is a systematic review of multiple, similarly designed randomized controlled trials with a large number of patients in each trial. Strong recommendations for patient care can be made from these reviews. The systematic review process has been formalized by the Cochrane Review Group, but can be performed on an individual basis. The criteria followed for the systematic review including the type of study, the number of patients enrolled, the analysis undertaken, and the controls provided should be carefully documented. With this type of review, much larger numbers of patients are able to be collated to evaluate the question being asked.

Levels of Evidence

The randomized controlled trial (RCT) is the highest level of evidence (level II) that a single institution or a single group of researchers can produce around a particular question. The RCT must have predetermined parameters for inclusion and exclusion, a sample size calculation for desired power and significance, and a regulatory process by which the entry of patients into the trial are monitored and the standardization of the procedure or process is achieved.

There are circumstances or institutions where randomized controlled trials cannot be performed. A case-matched control trial (CMCT) based on prospective or retrospective data collection is the next best alternative (level III) to achieve an answer for a clinical question. The case-matched control mechanism requires that multiple factors, which may or may not be related to the question being asked, be established to select the controls and compare with the prospective group of patients being enrolled. For example, in patients undergoing colectomy, the laparoscopic approach can be compared with the open approach based on selection by gender, age, disease process, medical severity index scores, body mass index (BMI), and stage of disease. Simply by standardizing these parameters, the prospective collected group can be compared with the retrospective evaluated group to provide a more homogeneous population upon which to perform statistical analysis.

The final level of evidence derived from a database evaluation of a prospective or a retrospective series provides only description statistics (level IV). The conclusion may be enhanced by performing a population-type study. Extremely large numbers derived from national databases can at times be considered high-powered evidence. However, the circumstances must be carefully controlled and one must be careful that selection bias, heterogeneity of the population, and outside influencing factors do not undermine the power of the analysis itself.

COLLABORATION POSSIBILITIES

Young investigators have numerous possibilities for getting started in clinical research. The first possibility is to establish a working group of investigators, with whom you are familiar, to combine database information, or to query national databases around a particular clinical question. It is possible to develop a consortium for establishing prospective studies around topics such as new technology, rare conditions, resident education, and expensive technology. In the past, clinical trials were almost exclusively run through the Cooperative Trials Groups for studying cancer. Now numerous trial groups are receptive to new members to look at issues specifically around the topic for which the trial group was established. The most frequently thought of Cooperative Trials Group subject is cancer. The American College of Surgeons Oncology Group, the Cancer and Lymphoma Group B, the National Surgical Adjuvant Bowel and Breast Project, the Eastern Cooperative Oncology Group, the North Central Cancer Trials Group, Southwest Oncology Group, and Radiation Therapy Oncology Group are all examples of groups that study cancer. It is easy to belong to one of these groups if your institution has an existing relationship or has the core resource backup needed to obtain membership. Individual private practitioners can belong as accruing members. These groups provide education and have yearly meetings at which they encourage participation in their established trials. Each member has the freedom to submit a potential protocol to the overall group regarding a specific question. The group as a whole will evaluate the protocol and may accept it as a protocol. The trial group must be willing to expend the funds given to it by the government (National Institutes of Health [NIH]) to answer the question.

Industry has become a major resource for sponsoring small clinical trials. Some are industry initiated, and the sponsor selects relevant investigators around their topic. Others can be initiated by an investigator or group of investigators. The industry sponsor can decide to provide funds for a multicenter trial adequate to answer a specific question. New technology has been evaluated in this way over the last two decades. This approach works well as long as the investigators remember the potential for bias from the industry partner. It is an important mechanism because governmental funds are rarely directed to evaluating new technology, new drugs, or implants in our patients.

Finally, the ASCRS has become a resource for young investigators. There are requests for proposals (RFPs) from the ASCRS Research Foundation for projects addressing the top 20 research topics revealed through a Delphi project. 1 A new committee of the ASCRS, called the Research Development Committee headed by Dr. Walter Koltun, is designed to use the committee members, most of whom are young investigators, to begin the multicenter process of establishing projects that are important to our patients and practice. The ASCRS Foundation has also begun funding K23 (clinical) and KO8 (basic) projects through the NCI around the area of colon and rectal cancer. This mechanism requires a young investigator to dedicate 75% of his or her effort on a 2- to 5-year project. This time is covered by a combination of funds from the government and the ASCRS. It is important for our young members and upcoming researchers to understand these mechanisms for obtaining funding and support.

GETTING STARTED IN THE CLINICAL TRIAL MECHANISM

Developing a clinical trial mechanism de novo at an institution involves several key steps. Step I is to identify a potential project and work through the process previously stated to develop a hypothesis and the best method of answering this question. Step II is to hire a clinical trials coordinator or clinical research assistant (CRA) to coordinate the support services of the clinical trial. These individuals collect data, collate data, organize data, enter data, and solicit, enroll, and follow patients. Most of these individuals start at a salary of $35,000 and increase according to the responsibilities and the volume of patients enrolled in trials. The goal should be for the coordinator to become self-supporting through the trial mechanism as studies are funded and money is designated for coordinator support.

The Contracts Committee for the institution needs to approve participation in all outside funded clinical trials, especially those sponsored by the industry or government. Outside funding requires monitoring, and the Contracts Committee is the oversight body for making sure the funds are used appropriately.

Once the protocol is defined, determining the cost per patient is extremely important. This involves not only a calculation of the time that the clinical trial coordinator will invest but also the investigator's time, the cost of any laboratory testing, and any materials that are involved in the procedure. The IRB fee at most institutions is approximately $3,000. It is important to remember to assign this to the industry sponsor. The percent effort for each trial for a clinical trial coordinator should be somewhere between 10 to 15%. The principal investigator effort is probably less than 5% for a clinical trial in which the majority of effort will be made by the CRA. The usual calculated cost per patient enrolled into a clinical trial with long-term follow-up is close to $4,000 per patient. The Contracts Committee will also negotiate institutional indirect costs to be added to the contract. This figure can be as high as 50% of the direct costs. This places quite a burden on the investigator seeking industry sponsorship. However, it supports the hidden overhead for large institutions.

The next step would then be to submit the protocol and a stylized consent form to the IRB. The IRB consent should be written in eighth-grade language and easily understood by any individual. The protocol should be basic yet detailed enough to prevent numerous questions being returned to the investigator from the IRB. It is a long process, even when everything goes well; but if multiple queries are returned to the investigator, the IRB process can be drawn out to many months.

Outside funding requires that the billing matrix be notified to make them aware of potential conflicts in reimbursement for the study. This is a simple matter but involves more paper work for which the CRA should be responsible.

It is important to educate the office staff and the collaborating faculty of the inclusion/exclusion criteria and the basic outline on all active trials to make sure there is a cooperative effort to enroll patients. It is impossible for any individual investigator to develop an adequate volume and enrollment to reach the numbers required to achieve significance in a clinical trial question. Successful accrual can be predicted by determining the number of patients entering the practice with the condition of interest, dividing by two for those that will meet inclusion criteria of the study and dividing again by two to achieve the number that will consent to participate.

A secured area is needed for maintaining clinical trial report forms or CRFs. This means firewalls for the computer program, a locked room for storing notebooks, and limited access from other nonclinical trials-related personnel. At all times, the files and clinical report forms should be maintained as ready for an audit. There are several sources of audit that can put the investigation and the clinical trials process as risk. As mentioned earlier, the Data Safety Management Board (DSMB) of the institution, the IRB, the Office of Investigator General (OIG), the FDA, the industry sponsor, the clinical trials group (such as ACOSOG) can ask to audit the data which is being collected. The usual lead time notice for this audit is 2 weeks. In a fairly large study, the amount of time involved to clean the case report forms to achieve the audit readiness is much greater than the time from notification to audit.

OBTAINING IRB APPROVAL

As mentioned earlier, the key to successful IRB submission is to summarize your project so that a nonmedical person can understand the project, i.e., think like an eighth grader. Decision to submit research for IRB approval is fairly simple in today's research atmosphere. Any research that would be eventually published should receive IRB approval. There are several levels of IRB submission, which include expedited, routine, and extended or high-risk. The expedited group includes retrospective reviews of de-identified data from IRB-approved databases, survey of national organizational members, or the number of times the elevator sticks on your floor in the hospital. Routine refers to randomized controlled trials, case-matched prospective controlled trials, industry sponsored drug study, and comparison of surgical techniques using either randomized controlled trials or case-matched control reviews.

Extended or high-risk submissions include subjects such as genetic profiling, HIV (human immunodeficiency virus) population, pediatrics, studies in which patient data may be identifiable, and experimental high-risk drug studies. The category designation refers to the amount of effort that would be required to obtain IRB approval and, as a result, the number of pages in the IRB submission. Table ​ Table2 2 refers to the information that you will need to successfully achieve IRB approval. These categories may occur in a different order at different institutions, but the basic grouping is the same. The IRB in most institutions has an online submission process and every blank should be filled to accommodate their needs and to be successfully reviewed. One should automatically assume that the first submission will not be successful and that the IRB will return your submission with questions, a request for more detail and/or preliminary data. The newly graduated, first-time, submission investigator should not be discouraged or take any of these “returns to sender” as personal. It happens to all of us, even after many years of doing clinical research. It is part of the process. If the process is still confusing to the new investigator, one suggestion may be to apply for membership on your local IRB so that you become more familiar with the process and thereby take away the unknown and the secrecy that is presumed to be part of the process.

Institutional Review Board (IRB) Submission: What You Need to Start

ESSENTIALS FOR DEVELOPING A RESEARCH-FOCUSED SECTION

As mentioned earlier, the first steps are to hire a database manager, establish a database, and hire a clinical trials coordinator. This initial outlay of money should be something that each new investigator requests from the department during the hiring process. Although almost all clinical trials research funding comes from operations and funding derived from the clinical trial itself, the initial startup cost is something that most departments should be able to accommodate and would be most helpful to any young investigator.

Make the IRB submission easy by learning the process, either by joining the team or spending time looking at the electronic version. Hire someone to manage the paperwork, such as a secretary or your clinical trials coordinator and think like an eighth grader.

Each new investigator will have a blank slate. As a new surgeon begins operating, keeping an easy erase board in the office to keep a list of projects for clinical trials, retrospective review questions, or basic science questions may be helpful to remind the new investigator that there are still unknown areas around the area of colon and rectal surgery. These projects can be checked off as the trials are developed. Residents, fellows, and other investigators sometimes utilize the project list as starting points for their own projects and would obviously include the generator of the idea in the collaborative effort.

It is important to make contacts for collaborative projects. This would include establishing groups of researchers based on like-minded fellows from the fellowship class from which you recently graduated or the ASCRS Research Foundation Grant Review Group, of which Dr. Garcia-Aguilar is the president. Introduction to industry representatives in the marketing or research and development groups can open doors to participating in comparative effectiveness research or establishing safety for new technology. Institutional or departmental research groups, such as the PRMC, IRB, or DSMB will be populated by institutional researchers. Getting to know these individuals can open doors for participation, collaboration, and guidance mentoring from senior investigators looking for new ideas and enthusiastic individuals willing to work. It may be necessary to join a cooperative group, and the institution may have to pay money for membership. In most circumstances, a university will already belong to most of these cooperative trial groups. If so, the new investigator should ask to attend the cooperative trial group meeting to learn more about establishing a clinical trials research program within colon and rectal surgery.

Publishing background data around the area of interest by submitting a review article or a retrospective background data review is appropriate at the beginning of a career. Prospective series with case control usually comes with more operative experience. Early on, this may be possible if the investigator is in a well-established group with several active senior members willing to share their patient data. Once the investigator has become well established, then a randomized controlled trial or phase two study process may become possible and important outcomes will be available for publication and treatment changing conclusions.

Once the individual institution and investigator have become established and data has been published, it is important to publish multiinstitutional data to confirm the single institutional data. The studies should also be able to generalize the findings to community practice. It is important that an investigator look critically at the results of recently completed trials to identify unanswered or newly revealed questions. This sets up the process to be self-perpetuating. Any good study will have numerous questions and may only have one answer. The questions are probably the most important product of the completed research from an investigator point of view.

It is important as you begin your pathway into clinical research that the regulatory and mechanistic issues not become onerous and act as anchors to your progress. Remember that clinical trials are one of the most rewarding parts of being an academic physician. Above all, as you design trials, collect data, and publish reports, it is important to remember to enjoy yourself and enjoy the fact that clinical research will inevitably have an impact on your patient's care. Good luck.

The author is an academic surgeon at Washington University, St. Louis, Missouri.

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