Title

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

Document Type

Article

Publication Date

7-1-2017

Identifier

DOI: 10.1016/j.jpedsurg.2016.11.042

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.

Journal Title

Journal of pediatric surgery

Volume

52

Issue

7

First Page

1084

Last Page

1088

MeSH Keywords

Academic Medical Centers; Biomedical Research; Cooperative Behavior; Humans; Multicenter Studies as Topic; Pediatrics; Program Development; Retrospective Studies; Specialties, Surgical; United States

Keywords

Clinical research; Multi-institutional trials; Research consortium

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