Selecting trial centers using a standardized, automated site assessment survey instrument (SASI).

Autor: Lane K; Department of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: klane@jhmi.edu., Hillery S; Department of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: shiller1@jhmi.edu., Majkowski R; Department of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: rmajkow1@jhmi.edu., Barney BJ; Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA. Electronic address: bradley.barney@hsc.utah.edu., Amirault D; Department of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: amirault@vrtx.com., Nelson SJ; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA. Electronic address: sarah.j.nelson@vumc.org., Bailey M; Duke Clinical Research Institute, Durham, NC, USA. Electronic address: mary.bailey@duke.edu., Unsicker EH; Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA. Electronic address: EunHea.Unsicker@hsc.utah.edu., Stroud M; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA. Electronic address: mary.stroud@vumc.org., Eyzaguirre LM; Department of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: LEyzaguirre@jhu.edu., Gawad A; Department of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: agawad1@jhu.edu., Nanni A; Department of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: ananni2@jhu.edu., Mirzoyan G; Wake Forest University School of Medicine, Winston-Salem, NC, USA. Electronic address: gmirzoya@wakehealth.edu., Cohen T; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA., Waddy SP; National Center for Advancing Translational Sciences, Bethesda, MD, USA. Electronic address: salina.waddy@nih.gov., Wiley K; National Center for Advancing Translational Sciences, Bethesda, MD, USA. Electronic address: ken.wiley@nih.gov., Harris PA; Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: paul.a.harris@vumc.org., Ford DE; Department of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA. Electronic address: dford@jhmi.edu., Hanley D; Department of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. Electronic address: dhanley@jhmi.edu.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2024 Aug; Vol. 143, pp. 107583. Date of Electronic Publication: 2024 May 29.
DOI: 10.1016/j.cct.2024.107583
Abstrakt: Background: To improve the site selection process for clinical trials, we expanded a site survey to include standardized assessments of site commitment time, team experience, feasibility of tight timelines, and local medical community equipoise as factors that might better predict performance. We also collected contact information about institutional research services ahead of site onboarding.
Aim: As a first step, we wanted to confirm that an expanded survey could be feasible and generalizable-that asking site teams for more details upfront was acceptable and that the survey could be completed in a reasonable amount of time, despite the assessment length.
Methods: A standardized, two-part Site Assessment Survey Instrument (SASI), examining qualitative components and with multiple contact list sections, was developed using a publicly accessible dashboard and later transferred to a REDCap platform. After multiple rounds of internal testing, the SASI was deployed 11 times for multicenter trials. Follow-up questionnaires were sent to site teams to confirm that an expanded survey instrument is acceptable to the research community and could be completed during a brief work shift.
Results: Respondents thought the SASI collected useful and relevant information about their sites (100%). Sites were "comfortable" (90%) supplying detailed information early in the site selection process and 57% completed the SASI in one to two hours.
Conclusions: Coordinating centers and sites found the SASI tool to be acceptable and helpful when collecting data in consideration of multicenter trial site selection.
Competing Interests: Declaration of competing interest Bradley Barney's relationship with Johns Hopkins University includes: consulting or advisory and receives financial support. Salina Waddy and Ken Wiley work for the National Institutes of Health.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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