Gender, Racial, and Ethnic Disclosure in NIH K-Award Funded Diabetes and Obesity Clinical Trials∗

∗This study was approved by the Duke University IRB and Ethics Committee.

Abstract

In 1993, the National Institutes of Health (NIH) passed The Revitalization Act (Subtitle B) which mandated that all NIH funded clinical trials have “appropriate representation” of minority and women subjects. Our aim was to evaluate the impact of the mandate by examining the reporting and inclusion of minority and female subjects into NIH K-Award funded clinical trials, addressing the minority predominant diagnoses of diabetes and clinical obesity. Using the CRISP search engine and PUBMED, we selected publications published by the National Institute on Aging (NIA) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) K-grant recipients during 1989–2004, associated with all the diabetes and obesity clinical trials. Studies were stratified into three timeline categories (1989–1993, pre-mandate; 1993–1996, post-mandate, and 1997–present, well past mandate) to evaluate trends in the recruiting of minorities and women before, during, and after the passing of the Revitalization Act. Of the 165 papers, only 37% disclosed race, a number that did not improve over time (p = .15), whereas 92% disclosed gender. Clinical trials that focused on females increased across the 3 timeframes (p < .001) for diabetes studies but not obesity studies. Overall, disclosure of race declined over the 3 timeframes whereas individually, the disclosure of African Americans improved.

Keywords:

• NIH Revitalization Act
• minority
• gender
• obesity
• diabetes
• K grant

Mr. Guevara, Dr. Cook, and Dr. Pietrobon were responsible for the study idea. Mr. Guevara, Dr. Cook, Ms. Herback, and Dr. Jacobs were responsible for writing the manuscript. Dr. Cook, Dr. Vail, and Dr. Pietrobon were responsible for the statistical analysis. Dr. Cook and Dr. Vail were responsible for the final editing of the article.

Notes

∗This study was approved by the Duke University IRB and Ethics Committee.

∗Median values instead of Std. Dev. Because these variables have non-normal distribution.

∗∗ Value for only one observation.

S.1 – National Institutes of Health Revitalization Act of 1993. Subtitle B—Clinical Research Equity Regarding Women and Minorities.