Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1 (1994) / Chapter Skim
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2 Women's Participation in Clinical Studies
2 Women's Participation in Clinical Studies
Pages 36-74
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From page 36... ...
, policies were formulated to protect human volunteers. Policies grounded in protectionist considerations contributed to the later exclusion of pregnant women and women of childbearing potential from some clinical studies, most notably, early-phase drug trials.
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From page 37... ...
The history begins with the early attempts to deal with ethical aspects of the use of human research participants. These efforts led to a period of public policy dominated by a protectionist agenda that is now being replaced by an emerging emphasis on expanded access to clinical studies.
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From page 38... ...
Research Abuses In the 1960s and 1970s, several unfortunate events demonstrated that serious problems remained with regard to the protection of human research subjects. Landmark research abuses, including those involving elderly, debilitated patients and African Americans, signaled the desperate need for the clarification and, more important, the formalization of existing guidelines for human subjects research.
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From page 39... ...
In the early 1970s, the abuses of the infamous Tuskegee Syphilis Study were revealed, adding fuel to arguments that human research subjects were not being adequately protected by the existing guidelines, and that more formal regulations were in order. This observational study of untreated syphilis, begun in 1932, involved approximately 400 African American men, many of whom were allowed to remain untreated for the disease, even after antibiotic treatment was widely available (Jones, 1981; King, 19921.
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Promulgated by DHEW, the regulations established the institutional review board (IRB) , a more formal version of the research review committee, as one mechanism for the protection of human research subjects.
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From page 41... ...
Although DHHS included restrictions on the inclusion of women of childbearing potential in earlier drafts of the regulation concerning pregnant women, these references were eliminated from the final regulation. In 1977, however, FDA issued guidelines for drug development that recommended that women of childbearing potential be excluded from early phases of drug trials (except in the case of life-threatening diseases)
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From page 42... ...
In May of 1987, the FDA issued regulations that expanded access to experimental drugs used to treat serious and life-threatening illnesses (Rothman and Edgar, 1990~. As described below, the success of AIDS activists would serve to energize the women's health movement.
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From page 43... ...
GAO also reported that the 1986 policy had not been well disseminated internally to individual institutes or centers, nor to prospective grant applicants, and therefore probably had not been implemented consistently, if at all. In addition, the GAO pointed to some of the larger, more expensive NIH-funded clinical studies that had included only men as evidence of the ineffectiveness of the policy.
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From page 44... ...
Why had the NIH-sponsored Multiple Risk-Factor Intervention Trials (MRFIT) of heart disease not included women when women as well as men were dying of heart disease?
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From page 45... ...
Later in October of 1992, the GAO released a second report that addressed the inclusion of women in clinical studies. The report examined the FDA's policies and the pharmaceutical industry's practices regarding experimental drug testing in women.
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From page 46... ...
This report will include an analysis of data collected from all NIH institutes since the institution of the 1991 policy regarding the inclusion of women and racial and ethnic groups in clinical studies. Recently NIH announced plans to convene a conference to discuss the establishment of a database for tracking and monitoring clinical trials data, including data on gender composition.
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From page 47... ...
And, in the case of at least one clinical study registry, information on gender composition of study populations was not collected until relatively recently. When GAO sought to ascertain the extent of NIH implementation of its 1986 policy on the inclusion of women in clinical studies, it found that NIH did not maintain consistent records on participation by gender.
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From page 48... ...
Because FDA did not maintain easily accessible records on gender composition of study populations, GAO chose to survey pharmaceutical companies directly. GAO concluded that women were "generally underrepresented" in the drug trials it examined and that trial data were not adequately analyzed for gender differences.
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From page 49... ...
The committee can conclude from this survey that there are many unanswered questions about gender-based differences in response to treatment, and that investigators may not have done one or more of the following: reported the results of gender analyses, performed gender analyses of study results, or recruited adequate numbers of women to support the kind of subgroup analysis that would be needed to resolve these questions. During the preparation of this report, the committee was advised that ORWH was preparing a follow-up report to the 1990 GAO report that summarizes clinical study data collected since 1991, when the NIH implemented an improved coding system for tracking and reporting data on gender and racial and ethnic group representation in all NIH-funded clinical studies.
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From page 64... ...
Thus, a failure to include people over 65 in clinical studies of heart disease has serious ramifications for women, who develop the disease later than men and are 20 years older at their first MI. It suggests that women's manifestations of heart disease may not have been adequately studied.
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From page 65... ...
MRFIT was a study of 12,866 men between the ages of 35 and 57, designed to assess the efficacy of intervention for individuals at high risk for coronary heart disease because of elevated serum lipids, hypertension, and cigarette smoking (Multiple Risk Factor Intervention Trial Research Group, 1977~. CDP was a randomized, controlled clinical trial designed to evaluate the efficacy of several different lipid-influencing drugs in prolonging the lives of men (age 30 through 64 at entry)
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From page 66... ...
Finally, in clinical trials of AIDS drugs, which often may provide significant sources of first-rate medical care and access to experimental treatments for persons with AIDS, the numbers of women participating lags behind expectations for a disease that is increasing the most rapidly among women. Perhaps more important, where women have been the focus of clinical research the primary research question has been how to reduce or prevent a vertical transmission of human immunodeficiency virus (HIV)
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From page 67... ...
Clinical Trial Registries The inability of the committee to draw conclusions from available data underscores the need for systematized collection of information by, at the very least, all federal agencies that conduct or support research involving human subjects. While these sorts of efforts have been undertaken in the past, they have not been wholly successful or enduring.
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From page 68... ...
The NIH Revitalization Act of 1993, passed in June 1993, promises to enhance the availability of information about women's participation in clinical studies. One provision of the act requires the directors of NIH, ORWH, and the National Library of Medicine (NLM)
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From page 69... ...
The NIH Revitalization Act's mandate that ORWH create a registry focused solely on women's health and the collection of women's health data is too narrow without information on men's health issues and men's levels of participation in such studies, monitoring of the relative levels of participation in the future will be difficult and open to bias. The committee supports the efforts of NIH to establish a registry of clinical studies and recommends that such a registry include information on the participation of women and men and on the racial and ethnic composition of participants in such studies, as well as the research questions addressed, that such information be reasonably accessible to investigators and the public, and that the scope of the studies included in the registry be comprehensive.
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From page 70... ...
The committee recommends that NIH work with other federal agencies and departments that conduct clinical research to ensure reporting of all federally funded clinical studies. The committee further recommends that representatives of NIH initiate discussions with FDA concerning the feasibility of including privately funded studies in such a registry.
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From page 71... ...
In: Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, A Mastroianni, R
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In: Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, A Mastroianni, R
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From page 73... ...
1993b. Memo to co-chairs of IOM Committee on the Legal and Ethical Issues Relating to the Inclusion of Women in Clinical Studies, 5 May.
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From page 74... ...
1993. Underrepresentation of women in clinical drug trials.
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