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The Inclusion of Women and Minorities in Smoking Cessation Clinical Trials: A Systematic Review
Author(s) -
Dickerson Daniel L.,
Leeman Robert F.,
Mazure Carolyn M.,
O'Malley Stephanie S.
Publication year - 2009
Publication title -
the american journal on addictions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.997
H-Index - 76
eISSN - 1521-0391
pISSN - 1055-0496
DOI - 10.1080/10550490802408522
Subject(s) - inclusion (mineral) , smoking cessation , medicine , clinical trial , subgroup analysis , representation (politics) , demography , population , gerontology , race (biology) , family medicine , psychology , meta analysis , political science , environmental health , gender studies , sociology , social psychology , pathology , politics , law
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.