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

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

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)2232-2237
Number of pages6
JournalStroke; a journal of cerebral circulation
Volume46
Issue number8
DOIs
StatePublished - Aug 1 2015

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Keywords

  • National Institutes of Health (US)
  • clinical trial
  • ethnic groups
  • health policy
  • stroke

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

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