Sean J Haley1, Lauren E Southwick2, Nina S Parikh2, Jazmin Rivera2, Dorothy Farrar-Edwards3, Bernadette Boden-Albala2. 1. CUNY School of Public Health and Health Policy, City University of New York, 55 West 125th St., New York, NY, 10027, USA. Sean.Haley@sph.cuny.edu. 2. Division of Social Epidemiology, College of Global Public Health, New York University, 41 East 11th St, 7th Floor, New York, NY, USA. 3. Department of Kinesiology, University of Wisconsin-Madison, 2176 Medical Sciences Center, 1300 University Avenue, Madison, WI, USA.
Abstract
INTRODUCTION: Randomized controlled trials (RCTs) are the gold standard within evidence-based research. Low participant accrual rates, especially of underrepresented groups (e.g., racial-ethnic minorities), may jeopardize clinical studies' viability and strength of findings. Research has begun to unweave clinical trial mechanics, including the roles of clinical research coordinators, to improve trial participation rates. METHODS: Two semi-structured focus groups were conducted with a purposive sample of 29 clinical research coordinators (CRCs) at consecutive international stroke conferences in 2013 and 2014 to gain in-depth understanding of coordinator-level barriers to racial-ethnic minority recruitment and retention into neurological trials. Coded transcripts were used to create themes to define concepts, identify associations, summarize findings, and posit explanations. RESULTS: Barriers related to translation, literacy, family composition, and severity of medical diagnosis were identified. Potential strategies included a focus on developing personal relationships with patients, community and patient education, centralized clinical trial administrative systems, and competency focused training and education for CRCs. CONCLUSION: Patient level barriers to clinical trial recruitment are well documented. Less is known about barriers facing CRCs. Further identification of how and when barriers manifest and the effectiveness of strategies to improve CRCs recruitment efforts is warranted.
INTRODUCTION: Randomized controlled trials (RCTs) are the gold standard within evidence-based research. Low participant accrual rates, especially of underrepresented groups (e.g., racial-ethnic minorities), may jeopardize clinical studies' viability and strength of findings. Research has begun to unweave clinical trial mechanics, including the roles of clinical research coordinators, to improve trial participation rates. METHODS: Two semi-structured focus groups were conducted with a purposive sample of 29 clinical research coordinators (CRCs) at consecutive international stroke conferences in 2013 and 2014 to gain in-depth understanding of coordinator-level barriers to racial-ethnic minority recruitment and retention into neurological trials. Coded transcripts were used to create themes to define concepts, identify associations, summarize findings, and posit explanations. RESULTS: Barriers related to translation, literacy, family composition, and severity of medical diagnosis were identified. Potential strategies included a focus on developing personal relationships with patients, community and patient education, centralized clinical trial administrative systems, and competency focused training and education for CRCs. CONCLUSION:Patient level barriers to clinical trial recruitment are well documented. Less is known about barriers facing CRCs. Further identification of how and when barriers manifest and the effectiveness of strategies to improve CRCs recruitment efforts is warranted.
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