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. 2018 Apr;93(4):630-635.
doi: 10.1097/ACM.0000000000002027.

The More Things Change, the More They Stay the Same: A Study to Evaluate Compliance With Inclusion and Assessment of Women and Minorities in Randomized Controlled Trials

Stacie E Geller  1 , Abigail R Koch, Pamela Roesch, Amarette Filut, Emily Hallgren, Molly Carnes
Affiliations

The More Things Change, the More They Stay the Same: A Study to Evaluate Compliance With Inclusion and Assessment of Women and Minorities in Randomized Controlled Trials

Stacie E Geller et al. Acad Med. 2018 Apr.

Abstract

Purpose: The National Institutes of Health (NIH) Revitalization Act of 1993 requires NIH-funded clinical trials to include women and minorities as participants and assess outcomes by sex and race or ethnicity. The objective of this study was to investigate current levels of compliance with these guidelines for inclusion, analysis, and reporting in NIH-funded randomized controlled trials (RCTs) and compare the results with those from 2009 and 2004, which the authors reported previously.

Method: The authors identified 782 RCTs published in 14 leading U.S. medical journals in 2015 with a PubMed search. Of those, 142 were the primary report of an NIH-funded RCT, conducted in the United States, and eligible for analysis. The authors reviewed abstract, text, and tables of each eligible study as well as any follow-up published commentary to determine compliance with NIH guidelines.

Results: Thirty-five studies limited enrollment to one sex. The median enrollment of women in the remaining 107 studies was 46%, but 16 (15.0%) enrolled less than 30% women. Twenty-eight of the 107 (26%) reported at least one outcome by sex or explicitly included sex as a covariate in statistical analysis. Of the 142 studies, 19 (13.4%) analyzed or reported outcomes by race or ethnicity. There were no statistically significant changes in inclusion, analysis, or reporting by sex, race, or ethnicity compared with the previous studies.

Conclusions: NIH policies have not resulted in significant increases in reporting results by sex, race, or ethnicity. The authors recommend strong journal policies to increase compliance with NIH policies.

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Figures

Figure 1
Figure 1
Flow chart of study eligibility for analysis, from a study evaluating compliance with NIH guidelines for inclusion and assessment of women and minorities in RCTs 2004, 2009, and 2015. Abbreviations: NIH, National Institutes of Health; RCT, randomized controlled trial.
See this image and copyright information in PMC

References

    1. Public Health Service Task Force on Women’s Health. Report of the Public Health Service Task Force on Women’s Health Issues. Vol. 100. Washington, DC: Public Health Service; 1985. - PMC - PubMed
    1. National Institutes of Health. Office of Research on Women’s Health. Report of the Advisory Committee on Research on Women’s Health, Fiscal Years 2013–2014: Office of Research on Women’s Health and NIH Support for Research on Women’s Health. National Institutes of Health; Bethesda, MD: 2015.
    1. National Institutes of Health. NIH Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research. Fed Regist. 1994;59:14508–14513.
    1. National Institutes of Health. Office of Extramural Research. NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October 2001. [Accessed October 5, 2017];2001 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html.
    1. U.S. Government Accountability Office. Rep to Congr Requesters. Washington, D.C.: Government Accountability Office; 2015. Better Oversight Needed to Help Ensure Continued Progress Including Women in Health Research. GAO-16-13.

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