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.
Key words
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References
- The role of prospective randomized clinical trials in pediatric surgery: state of the art?.J Pediatr Surg. 2001; 36: 1182-1186
- Evidence-based practice in pediatric surgery.J Pediatr Surg. 1999; 34 ([discussion 12-3]): 908-912
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- EA/TEF Study.American Academy of Pediatrics, Section on Surgery, Washington, DC2015
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- Oral presentation.American Academy of Pediatrics, San Francisco, CA2016
Article info
Publication history
Published online: January 09, 2017
Accepted:
November 28,
2016
Received in revised form:
November 17,
2016
Received:
August 5,
2016
Identification
Copyright
© 2016 Elsevier Inc. All rights reserved.