A Decision-Making Grid for Coenrollment in Multiple Clinical Trials.

Abstract

Background: While subject coenrollment into multiple trials is desirable, thoughtful consideration is required to avoid compromising each trial's scientific integrity.

Objective: We developed a Decision-Making Grid (GRID) to help investigators determine whether a clinical trial is compatible with a second clinical trial, thus allowing coenrollment, or if it should be considered competing, prohibiting coenrollment.

Methods: The GRID evaluates 21 elements across 4 domains: Scientific Integrity, Data Interpretation, Feasibility/Burden, and Additional Considerations. Optimally, each PI shares their protocol, completes the GRID independently, then meets to compare their perspectives, seeking a mutually acceptable agreement.

Results: The GRID has facilitated coenrollment decision-making for the RESTORE and PROSpect pediatric critical care clinical trials. In RESTORE, five trials were reviewed; one was approved for coenrollment; four were deemed competing. In PROSpect, 26 trials have been reviewed; 20 are approved for coenrollment; six were deemed competing. In both RESTORE and PROSpect, the PIs of multiple trials arranged a mutually acceptable sharing agreement.

Discussion: The GRID provides a systematic process to help investigators evaluate the effect of coenrollment in multiple clinical trials.