TY - JOUR
T1 - Examining Barriers and Practices to Recruitment and Retention in Stroke Clinical Trials
AU - Boden-Albala, Bernadette
AU - Carman, Heather
AU - Southwick, Lauren
AU - Parikh, Nina S.
AU - Roberts, Eric
AU - Waddy, Salina
AU - Edwards, Dorothy
N1 - Publisher Copyright:
© 2015 American Heart Association, Inc.
PY - 2015/8/1
Y1 - 2015/8/1
N2 - 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.
AB - 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.
KW - National Institutes of Health (US)
KW - clinical trial
KW - ethnic groups
KW - health policy
KW - stroke
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U2 - 10.1161/STROKEAHA.114.008564
DO - 10.1161/STROKEAHA.114.008564
M3 - Article
C2 - 26185186
AN - SCOPUS:84944704929
SN - 0039-2499
VL - 46
SP - 2232
EP - 2237
JO - Stroke; a journal of cerebral circulation
JF - Stroke; a journal of cerebral circulation
IS - 8
ER -