Improving site selection in clinical studies: a standardised, objective, multistep method and first experience...

Area of Science:

• Clinical Research
• Multicenter Studies
• Study Management

Background:

• Clinical studies, particularly multicenter ones, often face significant delays and cost overruns.
• Patient recruitment is a primary driver of delays in multicenter studies.
• Inadequate site selection negatively impacts recruitment rates and data quality, yet specific guidelines are lacking.

Purpose of the Study:

• To introduce and evaluate a novel, objective, multistep approach for selecting sites in multicenter studies.
• To provide a standardized methodology for improving site selection processes.
• To address the lack of specific guidelines for clinical trial site selection.

Main Methods:

• An open call via a network was used to solicit interested sites.
• A newly developed objective, multistep approach was employed for site selection.
• Key components included defining objective criteria, a systematic screening process, tailored questionnaires, and scripted telephone interviews.

Main Results:

• Out of 266 initially interested sites, 24 were shortlisted, and 12 were ultimately selected.
• The multistep process efficiently reduced the candidate pool at each stage.
• Despite some contracting issues, patient recruitment and data quality met expectations.

Conclusions:

• The standardized, objective site selection method yielded encouraging results in its initial application.
• This approach can serve as a valuable guideline for researchers conducting multicenter studies.
• The method demonstrates potential for improving the efficiency and success of clinical trial site selection.