Development of a multi-institutional clinical research consortium for pediatric surgery.
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.
Journal of pediatric surgery
Academic Medical Centers; Biomedical Research; Cooperative Behavior; Humans; Multicenter Studies as Topic; Pediatrics; Program Development; Retrospective Studies; Specialties, Surgical; United States
Clinical research; Multi-institutional trials; Research consortium
Hirschl, Ronald B.; Minneci, Peter; Gadepalli, Samir; Saito, Jacqueline M.; Askegard-Giesmann, Johanna; Deans, Katherine; Downard, Cynthia; Fallat, Mary; Finnell, Maria; Helmrath, Michael; Kabre, Rashmi; Lal, David; Leys, Charles; Mak, Grace; Ostlie, Daniel; Rescorla, Fred; Sato, Thomas; St Peter, Shawn D.; von Allmen, Daniel; Warner, Brad; and MidWest Pediatric Surgery Consortium (MWPSC), "Development of a multi-institutional clinical research consortium for pediatric surgery." (2017). Manuscripts, Articles, Book Chapters and Other Papers. 811.