Abstract

While subject coenrollment into multiple trials is desirable, thoughtful consideration is required to avoid compromising each trial's scientific integrity. 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. 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. 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. The GRID provides a systematic process to help investigators evaluate the effect of coenrollment in multiple clinical trials.

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