OP003 Topic: AS04–Emerging Sciences, Methodologies, Big Data and Technology: A DECISION-MAKING GRID FOR MULTIPLE CLINICAL TRIALS

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Aims & Objectives: Conducting multiple clinical trials simultaneously in a clinical unit may result in potential subjects being eligible for multiple trials. Though co-enrollment in multiple studies is optimal for recruitment needs, it may compromise the scientific integrity of these clinical trials. Methods: We developed a Decision-Making Grid to help Principal Investigators (PI) determine whether their clinical trial is compatible with a second trial, thus allowing co-enrollment, or if it should be considered competing, prohibiting co-enrollment. The Grid evaluates 21 data 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 solution or potential subject sharing scheme. Results: The Grid has facilitated co-enrollment decision-making for the RESTORE and PROSpect pediatric clinical trials. RESTORE was a 31-center cluster-randomized controlled trial (RCT) testing a sedation protocol. PROSpect is a 50+ center 2x2 factorial response-adaptive international RCT testing positioning and ventilation strategies. In RESTORE, 4 studies were reviewed; 1 (25%) was approved for co-enrollment; 3 (75%) were deemed competing. In PROSpect, 31 studies have been reviewed; 25 (81%) are approved for co-enrollment; 6 (19%) are deemed competing. In both RESTORE and PROSpect, the PIs of multiple trials were able to agree on a mutually acceptable solution. Conclusions: The Decision-Making Grid provides a methodical process to help PIs systematically evaluate the impact of conducting multiple studies simultaneously in a clinical unit. Keywords: Decision-making, clinical trials, co-enrollment

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