RECRUITING MINORITIES INTO CLINICAL-TRIALS - TOWARD A PARTICIPANT-FRIENDLY SYSTEM

The purpose of this review is to describe the state of the art in recr uiting participants for clinical trials designed to test new methods o f treatment or disease prevention, The ultimate objective of this revi ew is to provide a summary of key issues in recruiting diverse populat ions into clinical trials, particularly ethnic and racial minorities, An overview of general issues related to clinical trial participation is followed by a detailed discussion of specific issues that must be a ddressed by investigators as they recruit minority populations for cli nical trial, To date, the majority of clinical trials have included a limited segment of the U.S. population: middle-class, married white ma les, These trials have faced many problems in their efforts to recruit participants, including barriers to physician participation, barriers to subject participation, barriers to planning and implementing effec tive recruitment strategies, and costs of the recruitment phase of cli nical trials, Following this general introduction is a discussion of t he definition of diverse populations, The first step investigators mus t take as they prepare to recruit study participants is to develop a r elevant definition of the subject populations, A detailed review of in vestigators' experiences in recruiting minorities into clinical trials is presented, including barriers to minority recruitment, barriers in herent in study design, researcher bias, barriers to minority physicia n participation, as well as strategies for minority recruitment, modif ications of study design, and cost issues, Formal evaluation of recrui tment strategies has been limited, Most investigators present descript ive reports of their experience in recruiting diverse populations into clinical trials, Research into the issues presented and rigorous test ing of specific strategies is needed, A series of steps that are essen tial to effective clinical trials recruitment of diverse populations i s presented.