The inclusion of women and minorities in smoking cessation clinical trials: a systematic review.
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.
Dickerson
Daniel L
DL
Integrated Substance Abuse Programs, University of California at Los Angeles, Los Angeles, California 90025, USA. daniel.dickerson@ucla.edu
Leeman
Robert F
RF
Mazure
Carolyn M
CM
O'Malley
Stephanie S
SS
D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D004345:Drug Industry; D004358:Drug Therapy; D005260:Female; D006801:Humans; D008297:Male; D008913:Minority Groups / Q000706:statistics & numerical data*; D009316:National Institutes of Health (U.S.); D018579:Patient Selection; D016540:Smoking Cessation; D014481:United States; D014930:Women