Inclusion, Analysis, and Reporting of Sex and Race/Ethnicity in Clinical Trials: Have We Made Progress?
Top Cited Papers
- 1 March 2011
- journal article
- Published by Mary Ann Liebert Inc in Journal of Women's Health
- Vol. 20 (3), 315-320
- https://doi.org/10.1089/jwh.2010.2469
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. RCTs published in nine prominent medical journals in 2009 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. PubMed search located 512 published articles. After exclusion of ineligible articles, 86 (17%) remained for analysis. Thirty studies were sex specific. The median enrollment of women in the 56 studies that included both men and women was 37%. Seventy-five percent of the studies did not report any outcomes by sex, including 9 studies reporting <20% women enrolled. Among all 86 studies, 21% did not report sample sizes by racial and ethnic groups, and 64% did not provide any analysis by racial or ethnic groups. Only 3 studies indicated that the generalizability of their results may be limited by lack of diversity among those studied. There were no statistically significant changes in inclusion or reporting of sex or race/ethnicity when compared with 2004. Ensuring enhanced inclusion, analysis, and reporting of sex and race/ethnicity entails the efforts of NIH, journal editors, and the researchers themselves.This publication has 18 references indexed in Scilit:
- Sex bias in trials and treatment must endNature, 2010
- CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized TrialsAnnals of Internal Medicine, 2010
- Community-Based Participatory Research: A Review of the Literature With Strategies for Community EngagementJournal of Developmental & Behavioral Pediatrics, 2009
- Disparity in Outcomes of Surgical Revascularization for Limb SalvageCirculation, 2009
- Enrollment of Women in National Heart, Lung, and Blood Institute-Funded Cardiovascular Randomized Controlled Trials Fails to Meet Current Federal Mandates for InclusionJournal of the American College of Cardiology, 2008
- Statistics in Medicine — Reporting of Subgroup Analyses in Clinical TrialsThe New England Journal of Medicine, 2007
- Low Rate of Sex-Specific Result Reporting in Cardiovascular TrialsMayo Clinic Proceedings, 2007
- Females in Clinical Studies: Where are We Going?Clinical Pharmacology & Therapeutics, 2007
- Sex and gender bias in anatomy and physical diagnosis text illustrationsJAMA, 1994