Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1 (1994) / Chapter Skim
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Appendix A: Reports on Women's Participation in Clincal Studies, 1977-1993
Appendix A: Reports on Women's Participation in Clincal Studies, 1977-1993
Pages 213-232
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Appendixes
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The authors found that the percentage of all-male studies had dropped 15 percent while all-female studies had risen 22 percent. In addition, there was an increase in the number of both-sex studies that included some analysis of gender differences.
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This brief article describes data presented by researcher Dinah Reitman at the 1989 annual meeting of the American Public Health Association. Reitman compared the percentage of women enrolled in five categories of randomized control trials with the percentage of women affected by the corresponding medical conditions.
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It describes the Institute's efforts to recruit women as investigators in its research and training programs and as subjects in its clinical trials. Of the 18 NHLBI-initiated epidemiologic studies and primary prevention clinical trials active in 1990: · 2 included exclusively women; · 3 included between 30 and 45 percent women; · 10 included between 50 and 58 percent women; · 3 included exclusively men.
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: 1 6- 17. The authors examined the representation of women in federally funded clinical studies conducted by the National Cancer Institute's Clinical Trials Cooperative Group Program.
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and found a decline in the number of trials restricted to male subjects and a more than doubling of the number of trials that included both men and women. When the author extended the survey to clinical trials reported in all January issues of CP&T between 1981 and 1991, no consistent pattern (i.e., increase or decrease)
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They searched MEDLINE, major cardiology textbooks, meta-analyses, reviews, editorials, and the bibliographies of all identified articles. They conclude that age-based exclusions are frequently used in clinical trials of medications used in the treatment of acute myocardial infarction and that such exclusions limit the ability to generalize study findings to the patient population that experiences the most morbidity and mortality from acute myocardial infarction: persons over age 75 (60 percent of deaths from acute myocardial infarction occur in persons over this age)
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Women's Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing General Accounting Office (19 October 1992) This publication reports the results of a GAO survey of pharmaceutical industry practices regarding inclusion of women in clinical trials.
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A report from the Center for Women Policy Studies that makes recommendations for woman-focused HIV/AIDS research. The report states that women, intravenous drug users, people of color, and people of low income have been "grossly underrepresented" among study subjects in ACTG clinical trials.
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Prepared for the NIH/ORWH Public Hearing on the Recruitment and Retention of Women in Clinical Trials The author argues that women with AIDS/HIV disease have been explicitly or implicitly excluded from most clinical trials, whether sponsored by the government or by pharmaceutical manufacturers. She provides data indicating that women are not represented in ACTU (AIDS Clinical Unit)
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Meinert describes the findings of his survey of the reported gender and ethnic mix of trials published in a journal, Controlled Clinical Trials, from its inception to the present. Of a total of 38 papers describing actual clinical trials, only 28 provided explicit statements regarding gender inclusion criteria, and among those 28, only 21 provided exact
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. Letter to Curtis Meinert Regarding Gender Representation in Clinical Trials Performed by the National Heart, Lung, and Blood Institute National Heart, Lung, and Blood Institute (26 May 1993)
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Among clinical studies studying gender-neutral diseases, 49 percent had samples with women representing between one-third and two-thirds of their subjects. Among the remaining 51 percent, there was some fairly strong evidence to suggest that women were more likely to be underrepresented as research subjects compared with underrepresentation of men.
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veteran population and another 24 percent of these studies consisted of secondary analyses of single-gender studies, which tended to be all-male. These findings suggest that one important reason for a tendency for male-only studies to predominate is the differential opportunity for men to be in positions where clinical studies are likely to be funded and carried out (for example, receiving treatment in a Veterans Administration Medical Center or as a member of the armed services or as a prisoner)
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Schneider Regarding the Inclusion of Females and Males in Clinical Trials Supported by the National Cancer Institute National Cancer Institute (23 June 1993) This memo provides subject counts for NCI clinical trials in fiscal year 1992.
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The two anti-cancer drugs in the survey were studied principally for exclusively male conditions, prostate cancer and testis cancer. Food and Drug Administration Survey of NDAs, 1988 In an effort to examine selection bias, the FDA surveyed all drugs approved in 1988 (with the exception of 4 orphan drugs, 3 contrast agents for single dose uses, and a topical product for which gender distribution was not available)
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Clinical Pharmacology & Therapeutics 54: 11- 15. The authors performed a quantitative survey of gender distribution in test populations of trials reported in all issues of Clinical Pharmacology and Therapeutics (CP&T)
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exclusion of women from test populations, or (3) failure to analyze clinical trial data for gender differences.
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included subjects from other race-gender groups. Of these, 35 percent included white women, but only 14 percent presented any analyses of the white women specifically.
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