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A Guide to Organizing a Multicenter Clinical Trial

Chung, Kevin C. M.D., M.S.; Song, Jae W. M.D.WRIST Study Group

Plastic and Reconstructive Surgery: August 2010 - Volume 126 - Issue 2 - p 515-523
doi: 10.1097/PRS.0b013e3181df64fa
Hand/Peripheral Nerve: Outcomes Article

Summary: Multicenter clinical trials are important research tools. Planning a multicenter clinical trial is a long and arduous task that requires substantial preparation time. In this guide, the authors discuss the steps used to plan a multicenter clinical trial. A preplanning phase, which involves formulating and refining a research question and conducting pilot studies, is detailed, and the planning phase, which involves the acquisition of funding to support the coordination and preparation of a multicenter clinical trial, culminating in the submission of an R01 grant, is described. An essential asset to planning a multicenter clinical trial is the fluidity with which all collaborators work together toward a common vision. The philosophy among collaborators should be consensus and commitment and is emphasized by the development of a consensus-assisted study protocol. Most important are the recruitment of centers and co-investigators who are dedicated, collaborative, and selfless in the team effort to achieve goals that cannot be reached by a single-center effort.

Ann Arbor, Mich.

From the Section of Plastic Surgery, University of Michigan Medical School.

Received for publication December 20, 2009; accepted February 4, 2010.

The members of the WRIST Study Group are listed in Table 1.

Disclosure: None of the authors has a conflict of interest to declare.

Kevin C. Chung, M.D., M.S.; Section of Plastic Surgery; Department of Surgery; University of Michigan Health System; 1500 East Medical Center Drive; 2130 Taubman Center, SPC 5340; Ann Arbor, Mich. 48109-5340; kecchung@med.umich.edu

©2010American Society of Plastic Surgeons