The recruitment triangle: reasons why African Americans enroll, refuse to enroll, or voluntarily withdraw from a clinical trial. An interim report from the African-American Antiplatelet Stroke Prevention Study (AAASPS)

Abstract

Recruitment and retention of study subjects are key to the success of a clinical trial. In the case of minority patients, this may be challenging as minority patients have been underserved by the medical health-care system. Furthermore, minority patients are more likely to experience barriers to entry into a clinical trial such as mistrust of the medical system, economic disadvantages, lack of awareness of study programs, and communication barriers. An open-ended questionnaire was used to determine reasons why subjects in the African-American Antiplatelet Stroke Prevention Study (AAASPS) remained in the study or voluntarily withdrew in the absence of an adverse event. Potential enrollees who refused to participate in the AAASPS also were queried. Enrollees who remained in the program consistently stated that they participated to reduce the risk of stroke recurrence and to help others by finding a "cure" for stroke. Those who withdrew or refused to participate consistently stated that they were afraid of being used as "guinea pigs." A "recruitment triangle" emerged that might predict a patient's likelihood of participation in a clinical trial. The sides of the triangle include the patient, key family members and friends, and the primary medical doctor and other medical personnel. The organizers of a clinical trial need to be aware of the "recruitment triangle" and establish strategies to heighten and maintain its integrity.