Recruiting Minorities Into Clinical Trials Toward a Participant-Friendly System

Abstract

The purpose of this review is to describe the state of the art in recruiting participants for clinical trials designed to test new methods of treatment or disease prevention. The ultimate objective of this review is to provide a summary of key issues in recruiting diverse populations 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 addressed by investigators as they recruit minority populations for clinical trial. To date, the majority of clinical trials have included a limited segment of the U.S. population: middle-class, married white males. 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 effective recruitment strategies, and costs of the recruitment phase of clinical trials. Following this general introduction is a discussion of the definition of diverse populations. The first step investigators must take as they prepare to recruit study participants is to develop a relevant definition of the subject populations. A detailed review of investigators' experiences in recruiting minorities into clinical trials is presented, including barriers to minority recruitment, barriers inherent in study design, researcher bias, barriers to minority physician participation, as well as strategies for minority recruitment, modifications of study design, and cost issues. Formal evaluation of recruitment strategies has been limited. Most investigators present descriptive reports of their experience in recruiting diverse populations into clinical trials. Research into the issues presented and rigorous testing of specific strategies is needed. A series of steps that are essential to effective clinical trials recruitment of diverse populations is presented.

The success of recruiting minorities, women, and elderly into a randomized controlled effectiveness trial

“…[14][15][16][17][18] We first sent bilingual letters to patients that included the following information: their clinicians had given us permission to contact them; they would receive no experimental drugs or tests as part of the study; we would pay their transportation plus $50 for the interview and up to a total of $125 for later interviews; we would keep all their personal information confidential; and the study results might help improve care for people with their heart condition. The letter was written at a 6th grade reading level.…”

The Tuskegee Legacy Project: history, preliminary scientific findings, and unanticipated societal benefits

“…In fact, difficulties in recruitment have been identified as one of the foremost issues facing biomedical clinical researchers today [3,4]. Indeed, major programs funded by the NIH-such as the Women's Health Initiative (estimated to eventually cost in excess of $1 billion) and the vast majority of AIDS studies-currently face (and will continue to face) this challenge, as new drugs and treatment regimens are developed.…”

Recruitment and participation in clinical trials: Socio-demographic, rural/urban, and health care access predictors

“…1 Therefore, factors other than patient intent or willingness seem to impede participation in clinical trials. Some of the salient factors impeding participation in clinical trials include: being a racial minority; 2, 5-7 older age; 2, 5, 7-9 lower socioeconomic status; 2, 6, 7, 10, 11 lack of appropriate clinical trials and the disqualification of patients; 1 the reluctance of physicians to engage in accrual; 1,12 doctor-patient communications regarding clinical trials; 7, 10, 13 mistrust of academic institutions, research and the medical system; 6, 10, 12, 14-17 fear of negative effects; 11 lack of community and physician awareness and knowledge of clinical trials benefits; 10,11,18 lack of sufficient infrastructure (including oncologists and approved cancer programs) to support trials in community settings; 2 lack of researcher training in culturally appropriate patient concerns and communication methods; 13,17,19 certain historical factors; 14 lack of adequate support for community outreach; poor access to care; 12 and lack of information on available trials. 10,12 The low participation in cancer trials by African Americans and other minorities may contribute to existing cancer survival and mortality rate disparities.…”