Inclusion of Women in Clinical Trials Policies for Population Subgroups (1993) / Chapter Skim
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Inclusion of Women in Clinical Trials: Policies for Population Subgroups
Inclusion of Women in Clinical Trials: Policies for Population Subgroups
Pages 1-7
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. BACKGROUND Recent political and scientific arguments contend that although inclusion of women and minorities in medical research is necessary for valid inference about their health and disease, many medical studies have excluded or underrepresented both women and minorities.
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Medical researchers, caught betweer limited resources and many pressing medical questions, must consider sacrificing either statistical power or accurate representation of the population of interest. Clinical science now faces the challenge of providing information specific tc members of distinct population groups while economically collecting accurate information.
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This category includes women using contraception and those not currently sexually active, but not those who have had a hysterectomy or tubal ligation. Moreover, many of the largest clinical trials of cardiovascular disease have explicitly excluded women.
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No rules provide reliable guidance for planned the composition of the study cohort for a single study or for structuring a saner of studies to investigate a therapy in different populations. Rational choice oi cohorts in a clinical trial depends on the disease under investigation and the questions being asked, as well as on the conviction that the internal validity of a study translates into an ability to generalize to a more diverse population.
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INTERPRETATION OF AN UNEXPECTED OBSERVED DIFI~:RENCE BETWEEN MEN AND WOMEN When a study is designed to detect the main effect of treatment, if no reasonable hypothesis of important differences between subgroups exists, investigators must be cautious in interpreting surprising findings of differences. Although clinical trials are rarely large enough to test reliably a treatment effect within a subgroup of the population, most clinical trials report their results not only for the entire study cohort, but also for subgroups "of interest." For example, investigators typically report data from clinical studies separately for men and women even when the sample size is inadequate for that purpose.
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Similarly, including women in clinical trials in a ratio consistent with the prevalence of disease in both sexes may not provide reliable in~rmation about treatment. Neither is oversampling of women necessarily sufficient unless the realized sample sizes for men and women are large.
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An unusual cluster of events may spark suspicion that a therapy is harmful to a subgroup of people. For example, the surprising occurrence of vaginal cancer in a group of young women led to the implication of DES in the etiology of vaginal abnormalities in daughters of women who had taken the drug during pregnancy.26 More formal approaches to observational studies include many epidemiologic methods, the "Phase IV" postmarketing study, and outcomes research.27 The pharmaceutical industry is~currently studying some new approaches designed to expedite and improve the results of drug development activities.
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