Hirschl Ronald B, Minneci Peter, Gadepalli Samir, Saito Jacqueline M, Askegard-Giesmann Johanna, Deans Katherine, Downard Cynthia, Fallat Mary, Finnell Maria, Helmrath Michael, Kabre Rashmi, Lal David, Leys Charles, Mak Grace, Ostlie Daniel, Rescorla Fred, Sato Thomas, St Peter Shawn, von Allmen Daniel, Warner Brad
Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
J Pediatr Surg. 2017 Jul;52(7):1084-1088. doi: 10.1016/j.jpedsurg.2016.11.042. Epub 2016 Dec 27.
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.
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.
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.
Our model could be reproduced or adapted by other institutions to develop or strengthen other research collaboratives.
Type of study: retrospective, IV.
由于我们所治疗的许多疾病较为罕见，且协调和开展多机构研究存在困难，儿科手术的多中心临床研究大多局限于相对较小的病例系列和回顾性综述。创建一个合作研究网络可以提供开展高质量多机构研究所需的患者群体和基础设施。
2013年，美国境内的11个学术性儿科手术中心组建了一个研究联盟，以开发和开展多中心临床研究项目，推动儿科手术实践的发展。
我们介绍了创建、发展和维持该联盟的过程，包括最初的区域地理限制、制定章程及采用研究的规章制度和程序，以及研究基础设施，包括用于研究监测的中央网站和集中式机构审查委员会程序。
我们的模式可供其他机构复制或调整，以发展或加强其他研究合作。
研究类型：回顾性研究，IV级。
