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Institute of Medicine (US) Committee on Women's Health Research. Women’s Health Research: Progress, Pitfalls, and Promise. Washington (DC): National Academies Press (US); 2010.

Women’s Health Research: Progress, Pitfalls, and Promise.

• Hardcopy Version at National Academies Press

1 Introduction

Women make up just over half the US population (US Census Bureau, 2009) and should not be considered a special, minority population, but rather an equal gender whose health needs require equal research efforts as those for men. Historically, however, the health needs of women have lagged in medical research. In 1985, the Public Health Service Task Force on Women’s Health Issues, formed in light of the changing role of women in society, highlighted the need for research in women’s health and issued Women’s Health: Report of the Public Health Service Task Force on Women’s Health Issues (HHS, 1985). It concluded that the historical lack of research focus on women’s health concerns has compromised the quality of health information available to women as well as the health care they receive.

Since the publication of that report, there has been a transformation in women’s health research—including changes in government support of research, in policies, in regulations, and in organization—that has resulted in the generation of new scientific knowledge of women’s health. Offices on women’s health in the National Institutes of Health (NIH) and in the Substance Abuse and Mental Health Services Administration were mandated by law. Other offices focusing on women’s health were established in the Department of Health and Human Services (HHS), in its Food and Drug Administration (FDA) and Health Resources and Services Administration, and in other government agencies, and are now codified under the Patient Protection and Affordable Care Act of 2010 (Public Law [PL] 111-148).

A number of nongovernment organizations have also provided leadership in research in women’s health. Women as advocates, research subjects, researchers, clinicians, administrators, and US representatives and senators played a major role in building a women’s health movement.

Government Activities

In 1986, NIH established a policy for the inclusion of women in clinical research; 1 guidelines for the implementation of the policy were included in its 1987 Guide to Grants and Contracts . A similar policy encouraging enrollment of minority-group members was issued in 1987 (ORWH, 2009). Before that, little clinical research on women’s health was conducted, for reasons that included concern about ethical issues of possible fetal exposure to an experimental substance, the variability in hormonal status in women, comorbidities, the assumption that results of research on men could be extrapolated to women, and legal issues. Several developments led to a questioning of the exclusion of women from clinical trials: with the onset of the epidemic of the acquired immunodeficiency syndrome, clinical trials explicitly solicited only men, thereby denying to women the potential of a life-saving treatment; results of clinical trials in men were not being extrapolated to women, as seen in the initial unequal application of stents, beta blockers, and cholesterol-lowering drugs; and the male model did not always corresponds to health and disease status in women, especially with regard to cardiovascular disease (McCarthy, 1994; Merkatz and Junod, 1994). As a result of congressional inquiries, particularly from the bipartisan Congressional Caucus on Women’s Issues (Carnes et al., 2008), in the early 1990s the General Accounting Office 2 (GAO) reviewed how well NIH had implemented its 1986 policy 3 to encourage the inclusion of women in research study populations (GAO, 1990). GAO found that the policy was not well communicated within NIH or the research community; there were inconsistencies in application of the policy in the grant-review process; the policy applied only to extramural research, and the smaller intramural research program had no policy; and NIH officials took little action to encourage researchers to analyze results by sex. GAO also concluded that there was “no readily accessible source of data on the demographics of NIH study populations” and it was “impossible to determine the impact of the policy.” The resulting public outrage and response by Congress led to many of the developments in the early 1990s discussed below (Carnes et al., 2008). Table 1-1 highlights some of the milestones in women’s health research at the federal level.

Key Federal and Legislative Milestones in Women’s Health Research from 1977 to Present.

The National Institutes of Health Revitalization Act of 1993 (PL 103-43, Subtitle B, “Clinical Research Equity Regarding Women and Minorities”) required that NIH grantees include women and minority groups in human-subjects research and, for clinical trials, “ensure that the trial is designed and carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied in the trial affect women or members of minority groups, as the case may be, differently than other subjects in the trial.” 4 Cost was not allowed as an acceptable reason for exclusion. In addition, NIH developed a database to monitor compliance with the law. However, the law for clinical trials applied only to phase III trials. 5 The act also formalized the NIH Office of Research on Women’s Health (ORWH), which was established in September 1990, and charged it with reporting on progress related to the law throughout NIH. 6 Inclusion guidelines for complying with the law were published in 1994 and effectively stated that “that NIH could not and would not fund any grant, cooperative agreement or contract or support any intramural project … which did not comply with this policy” (NIH Tracking/Inclusion Committee, 2009).

In 2000, a second analysis by GAO documented that NIH had made significant progress toward the goal of including women and minorities in research. However, for the policy to have its intended effect, GAO emphasized that NIH needed to expand its focus beyond simple inclusion to ensure that, when it is scientifically appropriate, clinical trials be designed and carried out to allow for analysis by sex (GAO, 2000). NIH concurred with GAO’s recommendations and stated they would make efforts to improve tracking of statistical analysis of data on women in clinical trials (GAO, 2000).

In addition to the activities related to NIH discussed above, there have been several activities related to FDA. One of FDA’s primary regulatory responsibilities is to review applications for new drugs, biologics, and medical devices before they are marketed to the public. As part of that responsibility, the agency provides guidance for manufacturers that are conducting clinical trials and evaluating the safety and efficacy of new medical products. In 1977 guidance to manufacturers, FDA precluded women of childbearing potential from participating in phase I and early phase II trials (FDA, 1977) to avoid the possibility of exposing a fetus to a drug that had not satisfied preliminary safety and efficacy testing. Women of childbearing potential were permitted to participate in clinical trials that were conducted after evidence of a drug’s effectiveness in humans was obtained (that is, in late phase II and phase III trials) and after data from animal reproductive studies were examined to see whether the drug caused birth defects; but in practice, women were underrepresented in the later phases as well (GAO, 1992). However, there were concerns that if FDA approved drugs on the basis of clinical trials in which women were underrepresented, their effectiveness and safety in women would not be known (GAO, 1992; Haseltine and Jacobson, 1997). For example, a drug dose established in small early-phase clinical trials that used mostly men might be too high for women, especially because men typically weigh more than women.

Concerns led to a GAO review (1992) that found that although women were included in phase III clinical trials for all the drugs surveyed, they were generally underrepresented, especially in trials of cardiovascular drugs (GAO, 1992). The report recommended that FDA ensure that drug companies consistently include “sufficient numbers of women in drug testing to identify gender-related differences in drug response and that such sex differences are explored and studied.” In 1993, FDA issued a Federal Register (FR) notice (58 FR 39406), “Guideline for the Study and Evaluation of Gender Differences in Clinical Evaluation of Drugs,” which reversed the 1977 guidance and recommended inclusion of women in early-phase clinical trials. FDA also amended its regulations to require efficacy and safety data on sex, age, and racial subgroups (21 Code of Federal Regulation [CFR] Parts 312 and 314, February 11, 1998. Final Rule: Investigational New Drug Applications and New Drug Applications). The final published rule permits the agency to place a clinical hold 7 on one or more studies that is the subject of an investigational new drug application if men or women with reproductive potential are excluded from participation only because of the risk or potential risk of reproductive or developmental toxicity associated with use of the investigational drug (21 CFR 312, June 1, 2000. Final Rule: Investigational New Drug Applications: Amendment to Clinical Hold Regulations for Product Intended for Life Threatening Disease).

In 2001, GAO again reviewed the inclusion of women in clinical drug trials submitted to FDA and found that women made up a majority (52%) of the trial participants in the new drug applications (NDAs) examined and that every NDA included enough women in the pivotal studies to make it possible to determine statistically whether the drugs were effective in women (GAO, 2000, 2001). 8 However, GAO had three concerns (GAO, 2001):

There was a relatively small proportion of women in early small-scale safety studies, which provide important information on a drug’s toxicity and safe dosages for later stages of clinical development.

Although “most of the NDAs included analyses to detect differences between men and women, fewer of the NDAs explicitly included descriptions of both safety and efficacy analyses that compared women taking the drug with a comparison group of women taking a placebo or an alternative treatment,” and “NDA sponsors did not recommend different dosage levels for men and women based on the sex differences they detected.” Furthermore, GAO found “no evidence that any of the sex differences reported in any NDA on any dimension—safety, efficacy, or pharmacokinetics—even when statistically significant, were judged to be clinically relevant by either the NDA sponsors or the FDA reviewers, and no dose adjustments based on sex were recommended” (because NDA summary documents are not required to include analyses of sex differences, many of them do not, and FDA reviewers do not consistently request that information).

FDA lacks appropriate management systems to document the number of women in clinical trials, to comply with regulations for presenting outcomes data by sex, and to confirm that its reviewers have adequately addressed sex-related issues in their reviews.

Previous Institute of Medicine Report— Does Sex Matter?

In 2001, the Institute of Medicine (IOM) published Exploring the Biological Contributions to Human Health: Does Sex Matter? The committee that prepared the report focused on the basic differences between males and females that appear to have primarily biologic origins (that is, sex differences). Although it acknowledged the importance of social factors (such as female role expectations and socialization—that is, gender differences), it did not review data on those factors as health determinants. It also did not discuss the influence of reproductive factors (such as pregnancy, parity, and parenthood) on health (IOM, 2001), believing that these deserve a separate evaluation.

After a review of the evidence and discussions with scientific experts, that committee came to the following three overarching conclusions and the recommendations in Box 1-1 (IOM, 2001):

Recommendations from Exploring the Biological Contributions to Human Health: Does Sex Matter? Recommendations for Research Promote research on sex at the cellular level.

Sex matters. Being male or female is an important basic human variable and should be considered in designing and analyzing studies in all areas and at all levels of biomedical and health-related research.

The study of sex differences is evolving into a mature science. There is sufficient knowledge of the biologic basis of sex differences to validate their scientific study and to allow the generation of hypotheses.

Barriers to the advancement of knowledge about sex differences in health and illness exist and must be eliminated. Scientists conducting research on sex differences are confronted with barriers to progress, including ethical, financial, sociologic, and scientific factors.

Since that report, a large amount of research on women’s health has been conducted with a variety of research approaches, methods, and studies.

• CHARGE TO THE COMMITTEE

Given the differences that have been identified between men and women with regard to health and given the transformation in approaching women’s health and the increase in women’s health research conducted over the last 2 decades, in the Consolidated Appropriations Act of 2008 (PL 110-161) Congress provided the HHS Office on Women’s Health (OWH) with funds for the IOM “to conduct a comprehensive review of the status of women’s health research, summarize what has been learned about how diseases specifically affect women, and report to the Congress on suggestions for the direction of future research.” In response to that congressional language, the HHS OWH requested that the IOM conduct a study of women’s health research; the charge to the committee for the project is presented in Box 1-2 .

Charge to the Committee. An Institute of Medicine committee will examine what the research on women’s health has revealed; how that research has been communicated to providers, women, the public and others; and identify gaps in those areas. The (more...)

In response to that request, the IOM convened a committee of 18 members who have a wide variety of expertise, including expertise in biomedical research, research translation, research communication, disabilities, epidemiology, healthcare services, behavioral and social determinants of health, health disparities, nutrition, public health, women’s health, clinical decision making, and such other medical specialties as cardiovascular disease, mental health, endocrinology, geriatrics, and immunology.

This consensus report is the result of the committee’s research and deliberations.

THE COMMITTEE’S APPROACH TO ITS CHARGE

In light of the expansive nature of its charge, the broad expertise of the committee, and the audience for this report, the committee recognized the need to focus its information gathering, the need to ensure that terms are defined and used consistently, and the need to have an organizational framework. The committee’s information gathering approach, definitions, and framework are described below.

Definitions Used by the Committee

In Box 1-3 the committee defines a number of terms that will be used throughout this report. In 1946, the World Health Organization defined health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity” (WHO, 1946). The committee agrees that health is not merely the absence of disease and disability. The committee approached women’s health as a concept that has expanded beyond a narrow focus on the female reproductive system to encompass other conditions that create a significant burden in women’s lives. It confines its discussion of women’s health research to the scientific study of health conditions that are specific to women, are more common or more serious in women, have distinct causes or manifestations in women, or have different outcomes or treatments in women; and it includes the study of factors that are determinants of health (biologic, psychologic, environmental, and sociocultural factors), especially factors that might affect women disproportionately or uniquely.

Key Definitions. Women’s Health Research Women’s health research is confined for this report to the scientific study of health conditions that are specific to women, are more common or more serious in women, or have distinct causes, manifestations, (more...)

Being a man or a woman has a substantial influence on health as a result of biologic and sociocultural differences. It is important to distinguish sex-based differences and gender-based differences. The committee uses those terms as they were defined in the IOM report Exploring the Biological Contributions to Human Health: Does Sex Matter? (IOM, 2001). That report defined sex as “the classification of living things, generally as male or female according to their reproductive organs and functions assigned by chromosomal complement.” Gender is defined as “a person’s self-representation as male or female, or how that person is responded to by social institutions on the basis of the individual’s gender presentation. Gender is shaped by environment and experience.”

The committee is charged not only with highlighting what has been learned from women’s health research but with providing conclusions and recommendations related to the translation and communication of those research findings. For the purposes of this report, the committee defines research translation as the application or implementation of the findings of research studies in changes in health-care practice and public-health policies, and it defines health-research communication as the dissemination of the findings of research studies related to women’s health to the general public. As discussed in Healthy People 2010 (HHS ODPHP, 2009):

Health communication encompasses the study and use of communication strategies to inform and influence individual and community decisions that enhance health. It links the domains of communication and health and is increasingly recognized as a necessary element of efforts to improve personal and public health [Jackson and Duffy, 1998; NCI, 1989; Piotrow et al., 1997]. Health communication can contribute to all aspects of disease prevention and health promotion and is relevant in a number of contexts, including (1) health professional-patient relations, (2) individuals’ exposure to, search for, and use of health information, (3) individuals’ adherence to clinical recommendations and regimens, (4) the construction of public health messages and campaigns, (5) the dissemination of individual and population health risk information, that is, risk communication, (6) images of health in the mass media and the culture at large, (7) the education of consumers about how to gain access to the public health and health care systems, and (8) the development of telehealth applications [Atkin and Wallack, 1990; Backer et al., 1992; Eng and Gustafson, 1999; Freimuth et al., 1989; Harris, 1995; Jackson and Duffy, 1998; Maibach and Parrott, 1995; Northouse and Northouse, 1998; Ray and Donohew, 1990].

Information Gathering

The committee met six times, including two open information-gathering sessions at which the members heard from stakeholders and researchers. Appendix A presents the agendas of those public meetings. During that time, the NIH ORWH held a series of scientific workshops and public hearings involving a variety of stakeholders (health-care providers, public-policy experts, advocates, and the general public) to gather information to update its women’s health research agenda. Committee members or IOM staff attended portions of those meetings so that they could be aware of ORWH research–priority development and hear further stakeholder input on research priorities in women’s health.

The committee conducted extensive literature searches related to women’s health research and on the translation and communication of research findings in numerous databases, including PubMed and Embase. The committee focused on research published in the last 15–20 years, which is roughly the period during which policies were implemented to promote women’s health research. The committee’s evaluation included research on biologically determined sex differences in health and research on the influence of social, behavioral, and environmental factors on women’s health. Searches were conducted both on studies of women’s health research in general and on specific diseases, conditions, and determinants of health. Because of the large number of published articles, summaries and review articles were used when possible. Data from a broad spectrum of research were reviewed, including clinical trials, observational studies, basic research (spanning human, animal, and cellular studies), and research on healthcare services, such as women’s use of and access to high-quality health care. The committee focused on research relevant to the health of US women and to differential effects in groups of women.

In light of the breadth of the topic and the enormous base of published scientific articles, reviews, and summaries, the committee does not provide a comprehensive summary of findings of research related to women’s health but instead identifies selected conditions in which there has been progress. In addition, health issues in which progress has been lacking or narrowly limited and in which additional research is needed are mentioned; the committee focuses on a few examples that make it possible to identify overarching lessons and recommendations.

Focus of Charge

Given the breadth of its charge, the committee developed a series of questions to focus deliberations and ensure appropriate response to the charge. Although not officially outlined in the statement of task, the questions provided more specific tasks for the committee to use in addressing its overall charge. The questions are presented in Box 1-4 . The committee refers to those questions in this report to link the information in the various chapters to its charge.

Committee Questions to Focus Deliberations. Is women’s health research studying the most appropriate and relevant determinants of health? Is women’s health research focused on the most appropriate and relevant conditions and end points? (more...)

Framework for the Committee’s Work

Women’s health research (like health research in general) traditionally has been conducted with an organ- or disease-based approach. With advancing knowledge, however, it has become apparent that a woman’s health encompasses more than the sum of the absence or presence of discrete disease states and is much more complex. Moreover, health and disease are influenced by a number of factors and the interplay among them, including genetics; physiologic, psychologic, social, and environmental forces; and growth, development, and aging. Health research has expanded to be interdisciplinary and collaborative among specialties (for example, a clinical trial might be developed and conducted jointly by internists, oncologists, cardiologists, epidemiologists, psychologists, and nutritionists). The present committee was faced with a decision of whether to work with a disease-based framework, in keeping with the conduct and funding of most of the research reviewed, or to take an interdisciplinary approach by incorporating multiple determinants of health and considering health outcomes in addition to disease. The committee used both approaches. In Chapter 2 , health determinants are discussed in the context of an ecologic framework that distinguishes individual-level determinants of health (such as biologic and physiologic factors and health behaviors) from broader determinants of health (such as environmental and social determinants) (see, for example, Dahlgren and Whitehead, 1991; Evans and Stoddart, 1990; IOM, 2000). Such an approach is better suited to understanding not only the pathophysiology of a health outcome but also preventive measures that can help to ensure optimal health. When summarizing advances in the understanding of the biology and pathology related to women’s health in Chapter 3 , however, the committee organized findings by health outcome in light of the nature of the literature reviewed.

The committee did not conduct a comprehensive review of all research on all diseases, disorders, and conditions that are women’s health issues. It reviewed data on the status of women’s health in terms of morbidity and mortality, and it assessed improvements in those respects in the context of research that has been conducted on the various diseases and health issues. The overall leading causes of death in women from 1989 through 2006 are presented in Appendix B . The committee focused its review in Chapter 3 on progress that has been made in reducing mortality or morbidity associated with specific conditions. The committee also highlights a few conditions or diseases in which little progress has been made so that it can identify lessons learned and future needs.

Because the incidence and prevalence of conditions and the leading causes of mortality in women vary with age, it is important to remember that the main causes of death in women overall do not necessarily reflect the main health concerns and issues at different points in a women’s life cycle and that events that occur in one stage can affect health later in life. Furthermore, women have a longer life expectancy than men so many diseases of aging are of a greater concern for women than men.

The population of women in the United Sates is diverse and growing more so. As can be seen in Appendix B , demographic groups vary in the prevalence, incidence, and severity of conditions and their determinants. The committee has reviewed the data on disparities to determine whether research is being conducted on appropriate populations of women. The committee recognizes that different groups of women (such as lesbians, 9 military and veterans, prisoners, and disabled women) can have different health needs or benefit from different means of meeting their health needs. The committee has not compiled a comprehensive list of such populations but discusses the needs of particular groups as appropriate when data are available. Finally, in addition to health conditions, the committee considered such emerging issues as genetics and the effect of health information technology.

• ORGANIZATION OF THIS REPORT

The remainder of this report is organized in five chapters and three appendixes. Chapter 2 focuses on findings over the last 2 decades related to the determinants of health outcomes and diseases in women. Chapter 3 provides an overview of some of the major research advances of the last 1–2 decades in understanding the biology of women’s health, including the biology of conditions relevant to women and diagnosing and treating those health conditions. Those two chapters present the evidence that supports the committee’s conclusions regarding questions 1, 2, and 3 in Box 1-4 , that is, whether women’s health research is focused on the most appropriate and relevant determinants of health, the most appropriate and relevant health conditions, and the most relevant groups of women. In Chapter 4 , the committee looks at the methods that have been used in women’s health research on pathology and health determinants and draws conclusions related to question 4 in Box 1-4 , that is, whether, the most appropriate research methods are being used to study women’s health? The committee addresses questions 5 and 6, about how well research findings in women’s health have been translated into practice and communicated to women, in Chapter 5 . The committee’s findings are synthesized in Chapter 6 , which presents the committee’s responses to its six questions, a summary of the basis for its responses, and its overall conclusions and recommendations on women’s health research.

The report includes three appendixes. Appendix A presents the agendas of the open sessions held by the committee. Appendix B summarizes data on the overall causes of morbidity or causes of mortality in women. The committee used the latter information to focus its review of research on women’s health on issues that have the greatest impact on women. A number of large research studies or trials have been conducted in women in recent years, such as the Nurses’ Health Study and the Women’s Health Initiative. The findings of those studies are discussed in almost all the chapters in this report. To facilitate the discussions and avoid repetition of the descriptions of the study designs, Appendix C , which is included on the enclosed compact disk, describes those large trials.

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NIH definition of clinical research: “1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: a. Mechanisms of human disease, b. Therapeutic interventions, c. Clinical trials, and d. Development of new technologies. 2. Epidemiologic and behavioral studies. 3. Outcomes research and health services research” (HHS, 2009).

In 2004, the agency name was changed to Government Accountability Office.

According to GAO (1990), “although the policy first was announced in October, 1986, guidance for implementation was not published until July, 1989, and the policy was not applied consistently before the 1990 grant review cycles.”

The National Institutes of Health Revitalization Act of 1993 essentially reinforced the existing NIH policies but with four major differences: (1) that NIH ensure that women and minorities and their subpopulations be included in all clinical research, (2) that women and minorities and their subpopulations be included in phase III clinical trials in numbers adequate to allow valid analyses of differences in intervention effect, (3) that cost not be allowed as an acceptable reason for excluding these groups, and (4) that NIH initiate programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as participants in clinical studies (HHS, 2008).

According to NIH (2008), phase I trials are “initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients”; phase II trials are “controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks”; and phase III trials are “expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling.”

ORWH, in collaboration with the Office of Extramural Research and the Office of Intramural Research, monitors efforts for compliance, including convening a “trans-NIH” Tracking and Inclusion Committee. Inclusion of women and minorities in NIH-supported clinical research is documented by fiscal year in a series of reports, which are available to the public at http://orwh ​.od.nih.gov ​/inclusion/inclreports.html (accessed June 17, 2010). ORWH has also helped to develop outreach documents for investigators and study staff of NIH-supported research that include guidance on inclusion, recruitment, and retention of women and minorities in clinical research (ORWH, 2009).

A clinical hold is an order issued by FDA to the sponsor of an investigational new drug to delay or to suspend a clinical investigation.

In addition, in 2002, the FDA Office on Women’s Health funded an internal review of participation of women in clinical trials and sex analysis of data on biologics (such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins) for which a new product or biologic license application was approved by the Center for Biologics Evaluation and Research during calendar years 1995–1999. The review found that nearly equal numbers of men and women were participating in the trials. However, analysis of data by sex occurred for only a small number of the studies reviewed (FDA, 2009).

The IOM is currently preparing a report on lesbian, gay, bisexual, and transgender health issues as well as research gaps and opportunities.

• Cite this Page Institute of Medicine (US) Committee on Women's Health Research. Women’s Health Research: Progress, Pitfalls, and Promise. Washington (DC): National Academies Press (US); 2010. 1, Introduction.
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Putting science to work for the health of women

What Is Women's Health Research?

A person's health is influenced throughout their lifespan by many factors. Some of the most important factors include sex, gender, racial ethnicity, culture, environment, and socioeconomic status. Researchers are discovering the critical roles that sex (being male or female) and gender identity (including social and cultural factors) play in health, wellness, and disease progression. The discoveries being made through the study of women's health and sex differences are key to advancements in personalized medicine for both sexes.

There are striking sex and gender differences in many diseases and conditions, including:

• autoimmune diseases
• cardiovascular diseases
• depression and brain disorders
• infectious diseases
• substance abuse disorders

Women's health research is an essential part of the NIH research agenda. The field has expanded far beyond its roots in reproductive health and includes the study of health throughout the lifespan and across the spectrum of scientific investigations: from basic research and laboratory studies to molecular research, genetics, and clinical trials. Researchers are investigating healthy lifestyles and behavior, risk reduction, and disease prevention, and searching for the best ways to diagnose and treat chronic conditions.

For additional information, see the page " Sex/Gender Influences in Health and Disease ."

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Women’s health is massively underfunded and is one of the biggest missed opportunities in health

Women have traditionally been neglected in medical research, and conditions that affect women are chronically understudied. The good news is that even a small increase in funding goes a long way.

• 22 May 2023
• by Priya Joi

Women's health research is hugely underfunded when compared to spending on conditions that affect men, according to a new analysis of data from the US National Institutes of Health (NIH).

While this won't come as a surprise to women's health researchers, who have been advocating for more funding for years, the data published in Nature demonstrates the extraordinary extent to which women's health conditions are neglected.

“Cardiovascular disease, for example, is the number one killer of women in the USA, but only about a third of participants in clinical trials for new treatments for cardiovascular disease are female.” – Chloe Bird, professor of policy analysis at Pardee RAND Graduate School

It also shows how much opportunity there is to make an impact on women's health. Even a small increase in funding would reap a huge return on investment. When diseases are ranked by burden, disorders that disproportionately affect women – migraine, headaches, endometriosis and anxiety disorders, for example – are at or near the top.

When this is reordered according to funding, these conditions are mostly pushed to the back of the queue, behind issues such as HIV/AIDS and substance misuse, which disproportionately affect men.

The research also looks at the ratio of burden to funding. For chronic fatigue syndrome or myalgic encephalomyelitis (ME/CFS), which affects mostly women, the ratio is 0.04. For HIV/AIDS, by comparison, that affects more men than women, the ratio is 15.6.

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Historically, women have been neglected in much of medical research and have been underrepresented in clinical trials. Chloe Bird, professor of policy analysis at Pardee RAND Graduate School, explains that "Cardiovascular disease, for example, is the number one killer of women in the USA, but only about a third of participants in clinical trials for new treatments for cardiovascular disease are female."

Women of colour are even less visible in clinicals trials. For instance , in a 2015 publication on global cardiovascular drug trials, only 3.2% of women were black.

However, even the smallest bump up in funding can mean significant upticks in return on investment, says Bird. A collaborative study in 2021 between RAND and Women's Health Access Matters, overseen by Bird, ran a series of simulations looking at the return on investment if the NIH budget for studies assessing the health of women was doubled.

Doubling the NIH budget for research on coronary artery disease in women from its current $20 million, could mean a staggering return on investment of 9,500%. Research on rheumatoid arthritis in women receives just US$ 6 million a year – doubling that would deliver return on investment of 174,000%.

The results are striking. Doubling the NIH budget for research on coronary artery disease in women from its current $20 million, could mean a staggering return on investment of 9,500%. Research on rheumatoid arthritis in women receives just US$ 6 million a year – doubling that would deliver return on investment of 174,000%.

While these numbers are US-focused, the pattern of poor investment in women's health and the opportunity to see massive benefits through increased funding are global.

Ultimately researchers tend to go where the money is, and funders need to increase what is available for currently neglected health conditions. As neuroscientist Liisa Galea, at the Centre for Addiction and Mental Health in Toronto, Canada, told Nature , "If you put a pot of gold at the end of a funding rainbow, researchers are going to go for it."

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