Department of Neurology, Brain Injury Outcomes Division, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA.
Contemp Clin Trials. 2024 Aug;143:107583. doi: 10.1016/j.cct.2024.107583. Epub 2024 May 29.
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.
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.
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.
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.
Coordinating centers and sites found the SASI tool to be acceptable and helpful when collecting data in consideration of multicenter trial site selection.
为了改进临床试验的选址流程,我们扩大了选址调查范围,纳入了对选址承诺时间、团队经验、紧张时间安排的可行性以及当地医学共同体均衡性等因素的标准化评估,这些因素可能更好地预测表现。我们还在选址之前收集了机构研究服务的联系方式。
作为第一步,我们希望确认扩展调查是可行和可推广的,即要求选址团队提前提供更多详细信息是可以接受的,并且尽管评估篇幅较长,但调查可以在合理的时间内完成。
使用一个公开可访问的仪表板开发了标准化的、两部分的选址评估调查工具(SASI),该工具检查定性部分,并设有多个联系人列表部分。经过多轮内部测试,SASI 被用于 11 次多中心试验。向选址团队发送后续问卷,以确认扩展调查工具是否被研究界接受,并且可以在短暂的工作轮班内完成。
受访者认为 SASI 收集了有关其选址的有用且相关的信息(100%)。选址“愿意”(90%)在选址过程早期提供详细信息,57%的选址在一到两个小时内完成了 SASI。
协调中心和选址认为,在考虑多中心试验选址时,SASI 工具在收集数据方面是可接受和有帮助的。