Inclusion of Women in Clinical Trials -- Policies for Population Subgroups
Bennett, J. Claude
New England Journal of Medicine. 1993 Jul 22; 329(4): 288-292.
In summary, neither adherence to quotas in the composition of a study cohort nor the irrational exclusion of a subgroup of people can be supported scientifically. Determining the number of women to be included in a trial should reflect reasonable hypotheses about the relation of treatment efficacy to sex, not global rules about the composition of study cohorts.
Biomedical Research; Cancer; Clinical Trials; Discrimination; Evaluation; Federal Government; Females; Fetuses; Financial Support; Food; Government; Government Regulation; Health; Heart Diseases; Human Experimentation; Males; Pregnant Women; Public Policy; Regulation; Research; Research Design; Research Subjects; Selection of Subjects; Social Discrimination; Women's Health;
Institute of Medicine. Board on Health Sciences Policy
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