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Published Online: 12 March 2009

Participation of Women in Clinical Trials for New Drugs Approved by the Food and Drug Administration in 2000–2002

Publication: Journal of Women's Health
Volume 18, Issue Number 3

Abstract

Objective: This study aimed to track the inclusion of women in clinical trials for new drugs approved by the Food and Drug Administration (FDA) between 2000 and 2002 and to evaluate the extent of analyses by sex.
Methods: Data were extracted from FDA reviewers' reports, summaries of clinical trials in New Drug Applications (NDAs), and product labeling and organized into a Microsoft Access database. The information collected includes subject enrollment by sex per clinical phase and sex differences in pharmacokinetics, safety, and efficacy as determined by either sponsors or reviewers.
Results: There were 67 New Molecular Entities (NMEs) approved by the FDA between 2000 and 2002. A total of 397,825 subjects were enrolled in 2,323 clinical trials. If 9 sex-specific NMEs are excluded, 297,697 subjects were enrolled in 1,974 clinical trials. Forty-seven percent of participants were male, 49% were female, and 4% of subjects were not specified. Of the 58 sex-nonspecific products in the study, 71% (41 of 58) of sex analyses were performed either by the sponsor or FDA reviewers. Twenty-five NMEs were found to have sex differences in pharmacokinetics, efficacy or adverse events. However, no recommendation was made to adjust dosage based on sex differences.
Conclusions: The percentages of women and men participating in clinical trials varied by year, phase, and product type. However, the overall participation by women and men was comparable, suggesting an improvement in including more women in clinical trials when compared with the previous FDA study evaluating women's participation from 1995 through 1999. As with the previous study, however, a significant underrepresentation of women in early phase trials and in certain areas, such as cardiovascular products, was observed and continues to be an issue of concern. Lack of appropriate analyses by sex should also be noted as an issue of concern.

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Published In

cover image Journal of Women's Health
Journal of Women's Health
Volume 18Issue Number 3March 2009
Pages: 303 - 310
PubMed: 19243271

History

Published online: 12 March 2009
Published in print: March 2009
Published ahead of print: 25 February 2009

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    Yongsheng Yang, Ph.D.
    Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland.
    Alan S. Carlin, M.S.
    Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland.
    Patrick J. Faustino, Ph.D.
    Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland.
    Mónica I. Pagán Motta, B.Sc.
    The National Alliance for Hispanic Health, Washington, DC.
    Mazen L. Hamad, Ph.D.
    Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland.
    Ruyi He, M.D.
    Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland.
    Y. Watanuki, B.S.
    Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland.
    E.E. Pinnow, M.S.
    Food and Drug Administration, Office of Women's Health, Rockville, Maryland.
    Mansoor A. Khan, Ph.D.
    Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland.

    Notes

    Address reprint requests to:
    Yongsheng Yang, Ph.D.
    FDA/Center for Drug Evaluation and Research
    White Oak Life Sciences Building 64, Room 1024
    10903 New Hampshire Avenue
    Silver Spring, MD 20993
    E-mail: [email protected]

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