A guide to organizing a multicenter clinical trial.
A guide to organizing a multicenter clinical trial.
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DOI：
10.1097/prs.0b013e3181df64fa
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发表时间：
2010-08
影响因子：
3.6
通讯作者：
WRIST Study Group
中科院分区：
文献类型：
--
作者：
Chung KC;Song JW;WRIST Study Group
多中心临床试验是一种重要的研究工具。规划MCCT是一项长期而艰巨的任务，需要大量的准备时间。在本指南中，我们将讨论规划MCCT的步骤。详细说明了前期规划阶段，包括制定和完善研究问题并进行试点研究，以及规划阶段，其中涉及获得资金，以支持协调和编制母婴传播信托基金，最终提交R01赠款。规划MCCT的一项重要资产是所有合作者为实现共同愿景而共同努力的流动性。合作者之间的理念应该是共识和承诺，并通过制定共识辅助研究方案以及招募专注、合作和无私的中心和合作调查人员来强调这一理念，以实现单中心努力无法达到的目标。
Multicenter clinical trials (MCCTs) are an important research tool. Planning a MCCT is a long and arduous task that requires substantial preparation time. In this guide, we discuss the steps to plan a MCCT. A pre-planning phase, which involves formulating and refining a research question and conducting pilot studies, is detailed as well as the planning phase, which involves the acquisition of funding to support the coordination and preparation of a MCCT, culminating in the submission of an R01 grant. An essential asset to planning a MCCT is the fluidity with which all collaborators work together towards a common vision. The philosophy among collaborators should be consensus and commitment and is emphasized by the development of a consensus-assisted study protocol and the recruitment of centers and co-investigators who are dedicated, collaborative and selfless in this team effort to achieve goals that cannot be reached by a single center effort.