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

Ronald B. Hirschl, Peter Minneci, Samir Gadepalli, Jacqueline M. Saito, Ronald B. Hirschl, Peter Minneci, Samir Gadepalli, Jacqueline Saito, S. Maria Finnell, Katherine Deans, Cynthia Downard, Mary Fallat, Maria Finnell, Michael Helmrath, Rashmi Kabre, Frederick Rescorla, Charles Leys, Grace Mak, Daniel Ostlie, Fred RescorlaThomas Sato, Shawn St. Peter, Daniel von Allmen, Brad Warner

Research output: Contribution to journalArticle

4 Scopus citations

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.

Original languageEnglish (US)
JournalJournal of Pediatric Surgery
DOIs
StateAccepted/In press - Aug 5 2016
Externally publishedYes

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Keywords

  • Clinical research
  • Multi-institutional trials
  • Research consortium

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Surgery

Cite this

Hirschl, R. B., Minneci, P., Gadepalli, S., Saito, J. M., Hirschl, R. B., Minneci, P., Gadepalli, S., Saito, J., Finnell, S. M., Deans, K., Downard, C., Fallat, M., Finnell, M., Helmrath, M., Kabre, R., Rescorla, F., Leys, C., Mak, G., Ostlie, D., ... Warner, B. (Accepted/In press). Development of a multi-institutional clinical research consortium for pediatric surgery. Journal of Pediatric Surgery. https://doi.org/10.1016/j.jpedsurg.2016.11.042