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Abstract #158533

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Ellen Pinnow¹, Pellavi Sharma¹, Ameeta Parekh¹, Kimberly Thomas¹, Lina Aljuburi², and Kathleen Uhl¹. (1) Office of Women's Health, Food and Drug Adminstration, 5600 Fishers Lane, 16-65, Rockville, MD 20857, 301-827-0938, ellen.pinnow@fda.hhs.gov, (2) Center for Drug Evaluation and Research (CDER), Food and Drug Adminstration, 5600 Fishers Lane, Rockville, MD 20857

Women and minorities represent the majority of patients with diabetes. Women represent 47% of US diabetics (9.7 million). In 2006, 11.8% of African-Americans and 10.9% of Hispanics were diagnosed with diabetes compared to 6.6% of Caucasians. Minorities have the highest incidence of diabetes related complications. Women account for 52% of diabetes associated deaths. The Food and Drug Administration (FDA) requires that clinical trials include the population expected to use the drug. The purpose of this study is to evaluate if women and minorities are enrolled in clinical trials for oral diabetes drugs in proportion to their prevalence of diabetes.

Clinical data available in the Center for Drug Evaluation and Research Electronic Document Room for oral diabetes drugs were compiled from 69 studies on drugs approved between 1999 and 2006. Race was coded as Caucasian, African-American, Hispanic, Asian, Native American and Other in 59 studies. 10 studies coded race as Caucasian, African-American and Other. Sex was recoded to the M/F format.

Of the 27,405 participants enrolled, 38.9% were female and 61.1% male. 78.2% of participants were Caucasian and 6.3% African-American. For the trials with an expanded racial breakdown Caucasian, African-American, Hispanic, Asian and Native American, comprised 78.3%, 5.9%, 6.4%, 6.4%, and 0.1%, respectively.

This data demonstrate the under representation of women and minorities and the need for continued monitoring of participation of these groups in clinical studies. With increased diabetic morbidity and mortality in women and minorities, it is important that drugs be tested for safety and efficacy in sub-populations.

Learning Objectives: By the end of the session, the participant will be able to

• describe the current state of the of the inclusion of women and racial minorities in clinical trials for oral diabetes drugs.
• understand the importance of the inclusion of women and racial minorities in clinical trials.

Keywords: Women, Clinical Trials

Presenting author's disclosure statement:

Any relevant financial relationships? No
Any institutionally-contracted trials related to this submission?

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

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• Slides (pdf) or Handout