Overcoming Barriers to Recruitment and Retention of Ethnic & Racial Minority Populations in a Multi-site Clinical Trial: Lessons from the Bypass Angioplasty Revascularization Investigation of Type 2 Diabetes (BARI 2D)

Stephen B. Thomas, PhD, Graduate School of Public Health/Center for Minority Health, University of Pittsburgh, 130 DeSoto St., Parran Hall, Pittsburgh, PA 15261, Katherine Detre, MD, DrPH, Epidemiology Data Center, University of Pittsburgh, PUBHL, 127 Parran Hall, 130 DeSoto St., Pittsburgh, PA 15261, Tarek Helmy, MD, Cardiology, Grady Memorial Hospital, 80 Jesse Hill Drive, Atlanta, GA 30303, Veronica Sansing, BA, Center for Minority Health, University of Pittsburgh, 124 Parran Hall, 130 DeSoto Street, Pittsburgh, PA 15261, 412-624-7875, vsansing@cmh.pitt.edu, Elaine Massaro, MS, RN, CDE, Northwestern University Medical Center, 675 N St Clair St, Ste 14-100, Chicago, IL 60611, Patrice Desvigne-Nickens, MD, NHLBI-NIH, 2 Rockledge Ctr, 9044, 6701 Rockledge Dr, MSC 7940, Bethesda, MD 29892-7940, Margaret Jenkins, RN, Diabetology, Emory University, Emory Clinic A-4415, 1365 Clifton Rd, NE, Atlanta, GA 30322, Melissa Hill, MS, University of Chicago Medical Center, MC 5076, Rm M532, 5841 S. Maryland Avenue, Chicago, IL 60637, and Suzanne Gebhart, MD, FACP, Endocrinology, Diabetes & Medicine, Emory University School of Medicine, 1365 Clifton Rd, NE, Atlanta, GA 30322.

In 1993, the National Institutes of Health issued guidelines for the inclusion of women and minorities in clinical trials research. Implementation of these guidelines has presented both a challenge and opportunity for investigators to engage ethnic and racial minority populations as research participants. Numerous articles have documented the barriers to recruitment and retention of minorities in clinical research. This poster describes innovative strategies used to cross these barriers and recruit the said population into the Bypass Angioplasty Revascularization Investigation (Type) 2 Diabetes (BARI-2D). Funded by the National Heart Lung and Blood Institute (NHLBI), BARI-2D is a multi-center randomized epidemiological clinical trial focusing on patients with Type 2 Diabetes and stable coronary artery disease (CAD). The primary aims of the study are to determine the efficacy of: 1) initial elective coronary revascularization combined with aggressive medical management, compared to an initial aggressive medical management alone; and 2) insulin providing medications compared to insulin sensitizing medications. There are a total of 51 BARI-2D sites within the U.S., Canada, Latin America and Europe, with an overall recruitment goal of 2,300 participants by August 31, 2004. As of September 2003, a total of 1,347 participants were recruited, of which 36% (N= 487) were identified as racial/ethnic minorities. This article will describe the strategies used by the BARI-2D Minority Recruitment and Retention Working Group to overcome barriers to minority recruitment within BARI-2D sites in the U.S. Recommendations for replication of successful strategies to recruit minority participants into randomized clinical trials are discussed.

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: PCRN - Pittburgh Clinical Research Network: Performed needs assessment surveys for minority recruitment Jack Horner Communications: Public relations firm
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.