Martha A Q Curley, Laura Beth Kalvas, Mallory A Perry-Eaddy, Lisa A Asaro, David Wypij
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A Decision-Making Grid for Coenrollment in Multiple Clinical Trials.
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.
期刊介绍：
Nursing Research is a peer-reviewed journal celebrating over 60 years as the most sought-after nursing resource; it offers more depth, more detail, and more of what today''s nurses demand. Nursing Research covers key issues, including health promotion, human responses to illness, acute care nursing research, symptom management, cost-effectiveness, vulnerable populations, health services, and community-based nursing studies. Each issue highlights the latest research techniques, quantitative and qualitative studies, and new state-of-the-art methodological strategies, including information not yet found in textbooks. Expert commentaries and briefs are also included. In addition to 6 issues per year, Nursing Research from time to time publishes supplemental content not found anywhere else.
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