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, R. B., Minneci, P., Gadepalli, S., Saito, J. M., Askegard-Giesmann, J., Deans, K., Downard, C., Fallat, M., Finnell, M., Helmrath, M., Kabre, R., Lal, D., Leys, C., Mak, G., Ostlie, D., Rescorla, F., Sato, T., St Peter, S. D., von Allmen, D., Warner, B., . Development of a multi-institutional clinical research consortium for pediatric surgery. Journal of pediatric surgery 52, 1084-1088 (2017).