Adherence to federal guidelines for reporting of sex and race/ethnicity in clinical trials

Abstract

Background: The National Institutes of Health Revitalization Act of 1993 requires that NIH-funded clinical trials include women and minorities as subjects; other federal agencies have adopted similar guidelines. The objective of this study was to determine the current level of compliance with these guidelines in federally funded randomized controlled trials.

Methods: Randomized controlled trials published in nine influential medical journals in 2004 were identified by PubMed search. Studies where individuals were not the unit of analysis, those begun before 1994, and those not receiving federal funding were excluded. Included studies were examined to determine sample characteristics and presence of subgroup reporting.

Results: PubMed located 589 published papers. After exclusion of ineligible papers, 69 remained for analysis. Among 46 clinical studies enrolling both men and women, women were generally underrepresented, comprising on average 37% of the sample and only 24% of the sample when analysis was restricted to drug trials. Eighty-seven percent of the studies did not report any outcomes by sex or include sex as a covariate in modeling. Among all 69 studies, 18% did not break down sample sizes by racial and ethnic groups, and 87% did not provide any analysis by racial or ethnic groups. Only 5 studies indicated that the generalizability of their results may be limited by lack of diversity among those studied.

Conclusions: These findings illustrate inadequate compliance with the NIH guidelines. Researchers, editors, and journal audiences share the responsibility of ensuring compliance with our country's policies regarding federally funded research to effect healthcare improvements for all.