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)

Recruitment and retention of study subjects are key to the success of a clinical trial. In the case of minority patients, this may be challe nging as minority patients have been underserved by the medical health -care system. Furthermore, minority patients are more likely to experi ence barriers to entry into a clinical trial such as mistrust of the m edical system, economic disadvantages, lack of awareness of study prog rams, and communication barriers. An open-ended questionnaire was used to determine reasons why subjects in the African-American Antiplatele t Stroke Prevention Study (AAASPS) remained in the study or voluntaril y 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;cons istently stated that they were afraid of being used as ''guinea pigs.' ' A ''recruitment triangle'' emerged that might predict a patient's li kelihood of participation in a clinical trial. The sides of the triang le include the patient, key-family members and friends, and the primar y medical doctor and other medical personnel. The organizers of a clin ical trial need to be aware of the ''recruitment triangle'' and establ ish strategies to heighten and maintain its integrity.