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

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.