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

Abstract

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.