title: Gender, racial, and ethnic disclosure in NIH K-Award funded diabetes and obesity clinical trials.
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.
authors.affiliation: Duke University Medical Center, Durham, NC 27710, USA.
authors.forename: Carlos
authors.initials: C
authors.lastname: Guevara
authors.forename: Chad
authors.initials: C
authors.lastname: Cook
authors.forename: Natalie
authors.initials: N
authors.lastname: Herback
authors.forename: Ricardo
authors.initials: R
authors.lastname: Pietrobon
authors.forename: Danny O
authors.initials: DO
authors.lastname: Jacobs
authors.forename: Thomas Parker
authors.initials: TP
authors.lastname: Vail
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000706:statistics & numerical data*; D003920:Diabetes Mellitus / Q000175:diagnosis; D030881:Disclosure / Q000706:statistics & numerical data*; D005006:Ethnicity / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D009316:National Institutes of Health (U.S.) / Q000191:economics*; D009765:Obesity / Q000175:diagnosis; D044469:Racial Groups / Q000706:statistics & numerical data*; D012109:Research Support as Topic / Q000706:statistics & numerical data*; D014481:United States