Successful recruitment of minorities into clinical trials: The Kick It at Swope project.
Ethnic minorities are often underrepresented in clinical trials, and their recruitment can challenge researchers. Developing and communicating effective and efficient recruitment strategies may help researchers enroll more minorities into research studies. Kick It at Swope was a double-blind, randomized trial that evaluated bupropion for smoking cessation among 600 adult African Americans who smoked 10 or more cigarettes a day. Proactive recruitment strategies (in-person appeals by study staff and health care providers) and reactive recruitment strategies (disseminating information that asked people to call a study hotline) were implemented sequentially in an additive fashion over 16 months. Resulting patterns of recruitment are described and the two phases are compared based on their relative effectiveness, efficiency, and cost. More enrollees were recruited in the reactive phase (n=534) than in the proactive phase (n=66). Those recruited in the reactive phase were more likely to be eligible (OR=4.8) and more likely to be enrolled (OR=4.2) than those recruited in the proactive phase. Participants recruited in the reactive phase reported significantly higher levels of education and income, better health, and significantly lower indicators of depression and life hassles, compared with those recruited in the proactive phase. The reactive recruitment phase was less expensive than the proactive recruitment phase (22 US Dollars/enrollee vs. 159 US Dollars/enrollee). Reactive recruitment strategies added to multiple proactive clinic-based recruitment strategies were more effective, more efficient, and less costly than proactive recruitment alone. Close monitoring combined with the use of multiple recruitment methods and flexible recruitment plans can lead to successful, efficient, and low-cost recruitment of minorities into clinical trials.
Harris
Kari Jo
KJ
University of Kansas School of Medicine, Department of Preventive Medicine, Kansas City, KS 66160, USA. kharris2@kumc.edu
Ahluwalia
Jasjit S
JS
Catley
Delwyn
D
Okuyemi
Kolawole S
KS
Mayo
Matthew S
MS
Resnicow
Ken
K
D000328:Adult; D001741:Black or African American; D002986:Clinical Trials as Topic; D003365:Costs and Cost Analysis; D004311:Double-Blind Method; D004608:Eligibility Determination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008913:Minority Groups; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012907:Smoking / Q000188:drug therapy*; D016540:Smoking Cessation