The Inclusion of Women and Minorities in Smoking Cessation Clinical Trials: A Systematic Review |
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| Authors: | Daniel L. Dickerson DO MPH Robert F. Leeman PhD Carolyn M. Mazure PhD Stephanie S. O'Malley PhD |
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| Affiliation: | 1. Integrated Substance Abuse Programs, University of California at Los Angeles, Los Angeles, California;2. Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut;3. Daniel L. Dickerson and Robert F. Leeman are co‐primary authors.;4. Women's Health Research at Yale, New Haven, Connecticut |
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| Abstract: | This study assesses the impact of the 1993 NIH Revitalization Act on the inclusion and subgroup analysis of women and minorities in trials of FDA‐approved smoking cessation pharmacotherapy. Female representation, while commensurate with population levels, declined significantly for trials that began recruitment after 1993(M = 47.2% vs. M = 53.9%), and fewer than half reported analyses by gender. Minorities continued to be under‐represented in later trials; however, significant improvement in representation (M = 16.1% vs. M = 10%) and analysis by race occurred. Industry‐sponsored studies had lower minority representation than NIH funded studies. Recommendations are offered to improve subgroup analyses and minority inclusion. |
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