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J Pediatr Surg. 2017 Jul;52(7):1084-1088. doi: 10.1016/j.jpedsurg.2016.11.042. Epub 2016 Dec 27.

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

Author information

1
Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States. Electronic address: rhirschl@med.umich.edu.
2
Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.

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:

Clinical research; Multi-institutional trials; Research consortium

PMID:
28081853
DOI:
10.1016/j.jpedsurg.2016.11.042
[Indexed for MEDLINE]

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