Women's Health Research Progress, Pitfalls, and Promise (2010) / Chapter Skim
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1 Introduction
1 Introduction
Pages 15-34
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. 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.
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Several developments led to a questioning of the exclusion of women from clinical trials: with the onset of the epidemic of the acquired immunodefi ciency 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)
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The National Institutes of Health Revitalization Act of 1993 (PL 103-43, Subtitle B, "Clinical Research Equity Regarding Women and Minorities") re quired 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 be ing 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.
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WOMEN'S HEALTH RESEARCH TABLE 1-1 Key Federal and Legislative Milestones in Women's Health Research from 1977 to Present Year Event 1977 FDA restricts women of childbearing potential from participating in clinical research because of thalidomide and diethylstilbestrol tragedies 1985 Women's Health: Report of the Public Health Serice Task Force on Women's Health Issues concludes that "the historical lack of research focus on women's health concerns had compromised the quality of health information available to women as well as the health care they receive" 1986 NIH establishes policy to increase women's health research 1987 NIH issues guidelines urging inclusion of women for first time in NIH Guide to Grants and Contracts Nurses' Health Study focus is expandeda 1989 1990 Women's Health Equity Act is passed Breast and Cerical Cancer Mortality Preention Act establishes the CDC's National Breast and Cervical Cancer Early Detection Program GAO review of inclusion of women in clinical research concludes that • NIH policy on inclusion of women in clinical trials was not well communicated or understood within NIH or research community, was applied inconsistently among institutes, and was applied only to extramural research • There was "no readily accessible source of data on the demographics of NIH study populations," so it was impossible to determine whether NIH was enforcing its own recommendations 1990 NIH Office of Research on Women's Health is established by NIH and requires inclusion of women in clinical research 1991 HHS establishes Office on Women's Health WHI, largest clinical study in women, is launched by NIHb NIH ORWH launches strategic planning process to define research priorities for women's health research in NIH 1992 GAO issues report on inclusion of women in clinical trials used by FDA in evaluating drugs for marketing approval. The report finds that • Although women were sometimes included in drug trials, they were significantly underrepresented • Even when women were included, data were not analyzed to determine whether women's responses to drugs differed from those of men The report recommends 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" Mammography Quality Standard Act is signed into law.
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The new guideline • Encourages inclusion of women in phase I and II studies • Requires inclusion of women in efficacy studies • Requires analysis of data on sex differences • Encourages consideration of effects of menstrual cycle on drug effect, effects of exogenous hormone therapy on drug effect, and effect of drug on the effects of oral contraceptives, when feasible 1994 Offices of women's health are established in FDA and CDC SWAN, the first study on the natural history of menopause, is established c NIH guidelines on the inclusion of women and minority-group members as subjects in clinical research (first issued in 1990 and supported by 1993 NIH Revitalization Act) become effective on publication in Federal Register of March 28, 1994; guidelines state that NIH must: • "Ensure that women and members of minorities and their subpopulations are included in all human subject research; • For Phase III clinical trials, ensure that women and minorities and their subpopulations must be included such that valid analysis of differences in intervention effect can be accomplished; • Not allow cost as an acceptable reason for excluding these groups; and, • Initiate programs and support for outreach efforts to recruit these groups into clinical studies."d 1996 HHS OWH launches National Centers of Excellence in Women's Health; first six centers are established; program was later terminated 1998 NIH ORWH launches second strategic planning process to define research priorities for women's health research in NIH, and releases report, Agenda for Research on Women's Health for the st Century FDA publishes its final rule permitting agency to place clinical hold on investigational new drug application if men or women were excluded because of potential risk of reproductive or developmental toxicity 1999 AHRQ Centers for Education and Research of Therapeutics program begins.
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0 WOMEN'S HEALTH RESEARCH TABLE 1-1 Continued Year Event 2000 GAO issues followup audit of NIH that concludes that although women are in clinical trials at rates proportional to their numbers in general population, "NIH has made less progress in implementing the requirement that certain clinical trials be designed and carried out to permit valid analysis by sex, which could reveal whether interventions affect women and men differently" NIH ORWH initiates Building Interdisciplinary Research Careers in Women's Health program to support research career development of junior faculty members, known as Interdisciplinary Women's Health Research scholars, who have recently completed clinical training or postdoctoral fellowships and are commencing basic research, translational research, clinical research, or health-services research relevant to women's health 2001 Interim report released in January on GAO audit of FDA records reveals that 8 of last 10 drugs withdrawn from market caused more adverse effects in women than in men; 4 of those drugs were more often prescribed to women than to men, so the higher number of adverse events in women was not unexpected; other 4 drugs were prescribed equally to men and women, but number of adverse events was higher in women, and this suggested a true sex difference in incidence of adverse effects GAO final report on audit of FDA records reveals that • 30% of study documents examined failed to fulfill requirements for presentation of outcome data by sex • Nearly 40% of study documents examined did not include required demographic information Auditors conclude that "FDA has not effectively overseen the presentation and analysis of data related to sex differences in drug development." 2003 Study by FDA's OWH found that nearly equal numbers of men and women were participating in clinical trials but noted that data were not being analyzed by sex NIH establishes Specialized Centers of Research on Sex and Gender Factors Affecting Women's Health program to develop innovative approaches to advancing research on role of sex and gender factors in health and disease AHRQ begins the annual release of National Healthcare Quality Report and the National Healthcare Disparities Report that address various health care issues, including the following that were specific to women: disparities among women, including race, ethnicity, and socio-economic status; disparities between men and women; and trends and variations over time 2008 HHS implements strategic plan for 2010 through 2015
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dNIH defines a phase III clinical trial as "a broadly based .
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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)
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8 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.
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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 ap pear to have primarily biologic origins (that is, sex differences)
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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. 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.
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to health-care practices and public-health policies. Health Communication The dissemination of research findings to the public.
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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 recommenda tions 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.
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Because of the large number of published articles, sum maries 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)
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. 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.
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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.
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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.
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1994. Historical background of clinical trials involving women and minorities.
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1998. Health Communication: Strategies for Health Profes sionals.
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