Development of a Multi-Institutional Clinical Research Consortium for Pediatric Surgery

• Published in: Journal of pediatric surgery 2017-07, Vol.52 (7), p.1084-1088
• Main Authors: Hirschl, Ronald B, Minneci, Peter, Gadepalli, Samir, Saito, Jacqueline M
• Format: Article
• Language: English
• Subjects: Academic Medical Centers - organization & administration; Biomedical Research - organization & administration; Clinical research; Cooperative Behavior; Humans; Multi-institutional trials; Multicenter Studies as Topic; Pediatrics; Pediatrics - organization & administration; Program Development; Research consortium; Retrospective Studies; Specialties, Surgical - organization & administration; Surgery; United States
• ISSN: 0022-3468; 1531-5037
• DOI: 10.1016/j.jpedsurg.2016.11.042

Abstract Background Multi-center clinical research studies in pediatric surgery have been largely limited to relatively small case-series and retrospective reviews due to 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 multi-center 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. Type of Study Retrospective Level of Evidence IV