Increasing Minority Participation in Clinical Research

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2007

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Agodoa, Lawrence and Alanis, Alfonso J. and Alexander-Bridges, Maria and Doan, Loretta L. and Fleming, G. Alexander and Getz, Ken and Gibbs, Brian K. and Prothrow-Stith, Deborah The Endocrine Society (2007) Increasing Minority Participation in Clinical Research. Discussion Paper. UNSPECIFIED.

Abstract

Our goal is to ensure that clinical research supporting 1) the safety and efficacy of products for labeling purposes and 2) the validity of biomarkers commonly used to assess risk and to design therapeutic strategies is based on data sufficient for statistical power and derived from diverse subpopulations. It is widely recognized that data supporting therapeutic options for women and minorities have been deficient because these groups were not previously included in clinical trials. Although the combined efforts of Congress, the Office of Women’s Health at the Food and Drug Administration (FDA), and the Office of Research on Women’s Health…

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