Inclusion of Women in Clinical Trials: A Historical Overview of Scientific, Ethical, and Legal Issues
Merkatz, Ruth B.
Journal of Obstetric, Gynecologic and Neonatal Nursing. 1998 Jan-Feb; 27(1): 78-84.
During the past 20 years, there has been a dramatic shift in scientific, ethical, and legal perspectives regarding the inclusion of women in clinical trials conducted in the United States. A historical overview of why women previously were excluded from clinical trials is presented, and the reasons for current policy changes are discussed. The clinical necessity for testing drugs in specific populations (e.g., women) to ensure appropriate dose regimens and to minimize the likelihood of adverse effects is discussed. The difficult issue of prescribing drugs for pregnant women is highlighted.
Adverse Effects; Autonomy; Beneficence; Clinical Trials; Drug Industry; Drugs; Federal Government; Females; Food; Government; Guidelines; Health; Historical Aspects; HIV Seropositivity; Human Experimentation; Industry; Investigational Drugs; Justice; Legal Aspects; Legal Liability; Liability; Pregnant Women; Public Policy; Research; Research Subjects; Risks and Benefits; Women's Health;
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Merkatz, Ruth B.; Temple, Robert; Sobel, Solomon; Feiden, Karyn; Kessler, David A. (Working Group on Women in Clinical Trials, 1993-07-22)The Food and Drug Administration (FDA) is taking two important steps to ensure that new drugs are properly evaluated in women. First, it is providing formal guidance to drug developers to emphasize its expectations that ...