A Decision-Making Grid for Coenrollment in Multiple Clinical Trials

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BACKGROUND: Although 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 four domains: scientific integrity, data interpretation, feasibility/burden, and additional considerations. Optimally, each principal investigator shares their protocol, completes the GRID independently, and 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, and four were deemed competing. In PROSpect , 26 trials have been reviewed; 20 are approved for coenrollment, and six were deemed competing. In both RESTORE and PROSpect , the principal investigators 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.

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