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Development of a multi-institutional clinical research consortium for pediatric surgery.

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BACKGROUND Multicenter clinical research studies in pediatric surgery have been largely limited to relatively small case-series and retrospective reviews because of the rarity of many of the diseases we treat… Click to show full abstract

BACKGROUND Multicenter clinical research studies in pediatric surgery have been largely limited to relatively small case-series and retrospective reviews because of the rarity of many of the diseases we treat and difficulty coordinating and executing multi-institutional studies. Creation of a collaborative research network can provide the needed patient population and infrastructure to perform high quality multi-institutional studies. METHODS In 2013, eleven academic pediatric surgery centers within the United States formed a research consortium to develop and conduct multicenter clinical research projects to advance the practice of pediatric surgery. RESULTS We present our process for creating, developing, and maintaining this consortium including initial regional geographic limitation, charter development with by-laws and procedures for adopting studies, and research infrastructure including a central website for study monitoring and central reliance institutional review board process. CONCLUSION Our model could be reproduced or adapted by other institutions to develop or strengthen other research collaboratives. LEVEL OF EVIDENCE Type of study: retrospective, IV.

Keywords: research; consortium; pediatric surgery; multi institutional; clinical research

Journal Title: Journal of pediatric surgery
Year Published: 2017

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