title: A guide to organizing a multicenter clinical trial.
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.
authors.affiliation: Ann Arbor, Mich. From the Section of Plastic Surgery, University of Michigan Medical School.
authors.forename: Kevin C
authors.initials: KC
authors.lastname: Chung
authors.forename: Jae W
authors.initials: JW
authors.lastname: Song
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D003697:Delphi Technique; D005260:Female; D005380:Financing, Government; D017144:Focus Groups; D017408:Guidelines as Topic; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic / Q000592:standards*; D018579:Patient Selection; D010865:Pilot Projects; D011885:Radius Fractures / Q000601:surgery; D019651:Plastic Surgery Procedures / Q000592:standards*; D013518:Surgery, Plastic / Q000592:standards; D014481:United States; D014954:Wrist Injuries / Q000601:surgery