Underrepresentation of Women in New Drug Trials

Ramifications and Remedies

  1. EVLIN L. KINNEY, M.D.;
  2. JOANNE TRAUTMANN, Ph.D.;
  3. JAY ALEXANDER GOLD, J.D., M.P.H.;
  4. ELLIOT S. VESELL, M.D.; and
  5. ROBERT ZELIS, M.D.
  1. Hershey, Pennsylvania; and Houston, Texas

    Abstract

    Young women serve less frequently than young men as subjects in premarketing clinical drug trials. Moral, legal, and medical implications of this underrepresentation of women are considered. Risks of medical harm to female patients can increase because medication is withheld. Also, risks of toxicity increase when women receive certain new drugs only in the postmarketing phase. Remedies to increase participation of young, nonpregnant women in clinical trials are discussed.

    Article and Author Information

    • ▸From the Division of Cardiology, Department of Medicine, and the Departments of Humanities and Pharmacology, Pennsylvania State University College of Medicine, Hershey, Pennsylvania; and The Institute for the Interprofessional Study of Health Law, the University of Texas Health Science Center at Houston/University of Houston College of Law, Houston, Texas.

    • ▸Requests for reprints should be addressed to Elliot S. Vesell, M.D.; Department of Pharmocology, The Milton S. Hershey Medical Center; Hershey, PA 17033.

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    1. Ann Intern Med October 1, 1981 vol. 95 no. 4 495-499
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