EVALUATING MINORITY RECRUITMENT INTO CLINICAL-STUDIES - HOW GOOD ARE THE DATA

PURPOSE: There has been much publicized concern about difficulty with minority recruitment into research studies, particularly since minorit y inclusion in randomized clinical trials was mandated by the 1993 Nat ional Institutes of Health Revitalization Act. We reviewed recruitment data in published reports from clinical studies to assess the actual degree of success in recruiting minorities versus whites and to identi fy barriers to recruitment. METHODS: We abstracted articles published between September 1993 and February 1995 that reported detailed result s of participant recruitment for studies conducted in the United State s. RESULTS: Of 65 articles meeting our eligibility criteria (median sa mple size, 1323), only one (1.5%) reported the racial/ethnic compositi on of potential study participants. Only two articles (3.1%) provided information about the racial/ethnic composition of eligible subjects, and only one (1.5%) provided information about the racial/ethnic compo sition of refusing subjects. For enrolled subjects, race/ethnicity was less likely to be reported (58.5%) than were age (90.8%) or gender (8 0.0%). CONCLUSIONS: The published literature currently contains insubs tantial data to either refute or prove that there are differential rec ruitment rates among minorities as compared with whites. Changes in re porting will be needed in order to track progress in this area. (C) 19 97 Elsevier Science Inc.