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. 2015 Aug;46(8):2232-7.
doi: 10.1161/STROKEAHA.114.008564. Epub 2015 Jul 16.

Examining Barriers and Practices to Recruitment and Retention in Stroke Clinical Trials

Bernadette Boden-Albala  1 , Heather Carman  2 , Lauren Southwick  2 , Nina S Parikh  2 , Eric Roberts  2 , Salina Waddy  2 , Dorothy Edwards  2
Affiliations

Examining Barriers and Practices to Recruitment and Retention in Stroke Clinical Trials

Bernadette Boden-Albala et al. Stroke. 2015 Aug.

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.

Keywords: National Institutes of Health (US); clinical trial; ethnic groups; health policy; stroke.

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