Pitfalls of multisite randomized clinical trials of efficacy and effectiveness

Pitfalls of multisite randomized clinical trials of efficacy and effectiveness
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DOI:
10.1093/oxfordjournals.schbul.a033474
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发表时间:
2000-01-01
影响因子:
6.6
通讯作者:
Kraemer, HC
Kraemer, HC
中科院分区:
医学1区
文献类型:
--
作者:
Kraemer, HC

文献摘要

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本文讨论了多地点随机临床试验疗效和有效性的常见缺陷。考虑的问题包括:(1)过早启动,(2)无效的研究结构,(3)研究人员之间的交流过多或过少,(4)忽视地点差异,(5)使用“裸”p值,(6)过早关闭,以及(7)过度依赖个体研究人员的解释和记忆。如果未来的研究人员意识到这些常见的陷阱,他们可能能够避免它们。
This article discusses common pitfalls of multisite randomized clinical trials of efficacy and effectiveness. Issues considered include (1) premature initiation, (2) ineffective study structure, (3) too much or too little communication among researchers, (4) neglect of site differences, (5) use of "naked" p values, (6) premature closure, and (7) overreliance on the interpretation and memory of individual researchers. If future researchers are aware of these common pitfalls, they may be able to avoid them.