Affiliation:
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.).
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.
Publisher
Ovid Technologies (Wolters Kluwer Health)
Subject
Advanced and Specialised Nursing,Cardiology and Cardiovascular Medicine,Clinical Neurology
Cited by
45 articles.
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