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Inclusion, Analysis, and Reporting of Sex and Race/Ethnicity in Clinical Trials: Have We Made Progress?
March 2011
March 2011
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Abstract
The National Institutes of Health (NIH) Revitalization Act of 1993 requires that NIH-funded
clinical trials include women and minorities as participants; other federal agencies
have adopted similar guidelines. The objective of this study is to determine the current
level of compliance with these guidelines for the inclusion, analysis, and reporting
of sex and race/ethnicity in federally funded randomized controlled trials (RCTs)
and to compare the current level of compliance with that from 2004, which was reported
previously.