Recruitment of African American and white postmenopausal women into clinical trials: the beneficial effects of soy trial experience

Abstract

Objective: To describe the strategies and costs associated with recruiting both African American and White postmenopausal women into a randomized controlled trial.

Design: The Beneficial Effects of Soy Trial (BEST) was a randomized, controlled trial designed to determine the effects of a dietary soy supplement on lipoproteins, lipoprotein subclasses, and menopausal symptoms in African American and White postmenopausal women. The goal was to have > or = 80 African American and > or = 80 White women complete the study.

Results: A total of 705 postmenopausal women (381 African American, 324 White) were screened, and of those, 217 were randomized (105 African American, 112 White), and 192 (91 African American, 101 White) completed the study. Direct mailings to targeted zip codes proved the most successful recruitment strategy for recruiting African Americans (52% of African Americans recruited) and the second most effective for recruiting Whites (32% of Whites recruited). Newspaper advertisements yielded the highest number of White participants (36%) but proved less successful for recruiting African Americans (8%). Airing advertisements on the radio was the second most effective strategy for recruiting African Americans (15%), yet it was one of the least effective approaches for recruiting Whites (5%). The total cost of recruitment was dollar 49,036.25, which averaged dollar 255.40 per participant who completed the study. The three most successful strategies, direct mailings, newspaper ads, and radio ads, were the three most expensive approaches but yielded 73% of all participants who completed the study.