title: Examining Barriers and Practices to Recruitment and Retention in Stroke Clinical Trials.
abstract: OBJECTIVE
  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.
authors.affiliation: 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.). bb109@nyu.edu.
authors.forename: Bernadette
authors.initials: B
authors.lastname: Boden-Albala
authors.affiliation: 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.).
authors.forename: Heather
authors.initials: H
authors.lastname: Carman
authors.affiliation: 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.).
authors.forename: Lauren
authors.initials: L
authors.lastname: Southwick
authors.affiliation: 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.).
authors.forename: Nina S
authors.initials: NS
authors.lastname: Parikh
authors.affiliation: 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.).
authors.forename: Eric
authors.initials: E
authors.lastname: Roberts
authors.affiliation: 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.).
authors.forename: Salina
authors.initials: S
authors.lastname: Waddy
authors.affiliation: 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.).
authors.forename: Dorothy
authors.initials: D
authors.lastname: Edwards
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003625:Data Collection / Q000379:methods*; D005260:Female; D006801:Humans; D008913:Minority Groups; D018579:Patient Selection; D012108:Research Personnel; D020521:Stroke / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy; D014481:United States / Q000453:epidemiology; D014930:Women
keywords: National Institutes of Health (US); clinical trial; ethnic groups; health policy; stroke