Bernadette Boden-Albala1, Heather Carman2, Lauren Southwick2, Nina S Parikh2, Eric Roberts2, Salina Waddy2, Dorothy Edwards2. 1. From the College of Global Public Health (B.B.-A., H.C., L.S., E.R., N.S.P.), Department Neurology, Langone Medical Center (B.B.-A.), and Department of Epidemiology, College of Dentistry (B.B.-A.), New York University, New York, NY; National Institute of Neurological Disorders and Stroke at the National Institutes of Health, Rockville, MD (S.W.); and Department of Kinesiology, University of Wisconsin, Madison (D.E.). bb109@nyu.edu. 2. From the College of Global Public Health (B.B.-A., H.C., L.S., E.R., N.S.P.), Department Neurology, Langone Medical Center (B.B.-A.), and Department of Epidemiology, College of Dentistry (B.B.-A.), New York University, New York, NY; National Institute of Neurological Disorders and Stroke at the National Institutes of Health, Rockville, MD (S.W.); and Department of Kinesiology, University of Wisconsin, Madison (D.E.).
Abstract
BACKGROUND AND PURPOSE: The National Institutes of Health policy calls for the inclusion of under-represented groups, such as women and minorities, in clinical research. Poor minority recruitment and retention in stroke clinical trials remain a significant challenge limiting safety and efficacy in a general population. Previous research examines participant barriers to clinical trial involvement, but little is known about the investigator perspective. This study addresses this gap and examines researcher-reported barriers and best practices of minority involvement in stroke clinical trials. METHODS: Quantitative and qualitative methods, including surveys, focus groups, and key informant interviews were used. RESULTS: In a survey of 93 prominent stroke researchers, 43 (51.2%; 70% response rate) respondents reported proactively setting recruitment goals for minority inclusion, 29 respondents (36.3%) reported requiring cultural competency staff training, and 44 respondents (51.2%) reported using community consultation about trial design. Focus groups and key informant interviews highlighted structural and institutional challenges to recruitment of minorities, including mistrust of the research/medical enterprise, poor communication, and lack of understanding of clinical trials. Researcher-identified best practices included using standardized project management procedures and protocols (eg, realistic budgeting to support challenges in recruitment, such as travel/parking reimbursement for participants), research staff cultural competency and communication training, and developing and fostering community partnerships that guide the research process. CONCLUSIONS: This study's formative evaluation contributes a new dimension to the literature as it highlights researcher-reported barriers and best practices for enhancing participation of minority populations into stroke clinical trials.
BACKGROUND AND PURPOSE: The National Institutes of Health policy calls for the inclusion of under-represented groups, such as women and minorities, in clinical research. Poor minority recruitment and retention in stroke clinical trials remain a significant challenge limiting safety and efficacy in a general population. Previous research examines participant barriers to clinical trial involvement, but little is known about the investigator perspective. This study addresses this gap and examines researcher-reported barriers and best practices of minority involvement in stroke clinical trials. METHODS: Quantitative and qualitative methods, including surveys, focus groups, and key informant interviews were used. RESULTS: In a survey of 93 prominent stroke researchers, 43 (51.2%; 70% response rate) respondents reported proactively setting recruitment goals for minority inclusion, 29 respondents (36.3%) reported requiring cultural competency staff training, and 44 respondents (51.2%) reported using community consultation about trial design. Focus groups and key informant interviews highlighted structural and institutional challenges to recruitment of minorities, including mistrust of the research/medical enterprise, poor communication, and lack of understanding of clinical trials. Researcher-identified best practices included using standardized project management procedures and protocols (eg, realistic budgeting to support challenges in recruitment, such as travel/parking reimbursement for participants), research staff cultural competency and communication training, and developing and fostering community partnerships that guide the research process. CONCLUSIONS: This study's formative evaluation contributes a new dimension to the literature as it highlights researcher-reported barriers and best practices for enhancing participation of minority populations into stroke clinical trials.
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