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When and how can endpoints be changed after initiation of a randomized clinical trial?

作者信息

Evans Scott

机构信息

Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard School of Public Health, Harvard University, Boston, Massachusetts, United States of America.

出版信息

PLoS Clin Trials. 2007 Apr 13;2(4):e18. doi: 10.1371/journal.pctr.0020018.

DOI:10.1371/journal.pctr.0020018
PMID:17443237
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1852589/
Abstract
摘要

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Lancet. 2005 Oct 8;366(9493):1279-89. doi: 10.1016/S0140-6736(05)67528-9.
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Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research.由加拿大卫生研究院资助的随机试验中的结果报告偏倚。
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The prospective pioglitazone clinical trial in macrovascular events (PROactive): can pioglitazone reduce cardiovascular events in diabetes? Study design and baseline characteristics of 5238 patients.吡格列酮大血管事件前瞻性临床试验（PROactive）：吡格列酮能否降低糖尿病患者的心血管事件？5238例患者的研究设计与基线特征
Diabetes Care. 2004 Jul;27(7):1647-53. doi: 10.2337/diacare.27.7.1647.
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Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.随机试验中结果选择性报告的实证证据：方案与已发表文章的比较。
JAMA. 2004 May 26;291(20):2457-65. doi: 10.1001/jama.291.20.2457.
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On changing a long-term clinical trial midstream.关于在一项长期临床试验进行到一半时做出改变。
Stat Med. 2002 Oct 15;21(19):2789-95. doi: 10.1002/sim.1282.
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Journals should see original protocols for clinical trials.期刊应查看临床试验的原始方案。
BMJ. 2001 Dec 1;323(7324):1309. doi: 10.1136/bmj.323.7324.1309.
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The preliminary report of the findings of the aspirin component of the ongoing Physicians' Health Study. The FDA perspective on aspirin for the primary prevention of myocardial infarction.
JAMA. 1988 Jun 3;259(21):3158-60.
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