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Review
. 2010 Aug;126(2):515-523.
doi: 10.1097/PRS.0b013e3181df64fa.

A guide to organizing a multicenter clinical trial

Kevin C Chung  1 , Jae W Song; WRIST Study Group
Affiliations
Review

A guide to organizing a multicenter clinical trial

Kevin C Chung et al. Plast Reconstr Surg. 2010 Aug.

Abstract

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.

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Figures

Figure 1
Figure 1
Types of Pilot Studies: External and Internal Pilot Studies
Figure 2
Figure 2
Focused Group Discussion and Nominal Group Technique
Figure 3
Figure 3
Delphi Technique
Figure 4
Figure 4
The Pre-planning and Planning Phases of a Multicenter Clinical Trial
See this image and copyright information in PMC

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