2002 年至 2017 年随机临床试验的注册模式和主要结局变化。
Clinical Trial Registration Patterns and Changes in Primary Outcomes of Randomized Clinical Trials From 2002 to 2017.
机构信息
Department of Neurology, Haaglanden Medical Center, Den Haag, the Netherlands.
Department of Child Neurology, UMC Utrecht Brain Center, University Medical Center (UMC) Utrecht, Utrecht, the Netherlands.
出版信息
JAMA Intern Med. 2022 Jul 1;182(7):779-782. doi: 10.1001/jamainternmed.2022.1551.
Abstract
This cross-sectional study evaluates the existence and timing of trial registration for randomized clinical trials (RCTs) published from 2002 to 2017 as well as substantive changes to the primary outcomes entered into registry information after those studies started.
摘要
本横断面研究评估了从 2002 年到 2017 年发表的随机临床试验（RCT）的试验注册的存在和时间，并评估了这些研究开始后注册信息中主要结局的实质性变化。
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本文引用的文献
1
The preregistration revolution.预注册革命。
Proc Natl Acad Sci U S A. 2018 Mar 13;115(11):2600-2606. doi: 10.1073/pnas.1708274114.
2
Update on Trial Registration 11 Years after the ICMJE Policy Was Established.ICMJE政策制定11年后的试验注册最新情况。
N Engl J Med. 2017 Jan 26;376(4):383-391. doi: 10.1056/NEJMsr1601330.
3
Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study.在ClinicalTrials.gov上注册的临床试验中主要结局变化的患病率：一项横断面研究。
F1000Res. 2014 Mar 26;3:77. doi: 10.12688/f1000research.3784.1. eCollection 2014.
4
HARKing: hypothesizing after the results are known.结果已知后提出假设（HARKing）：结果已知后进行假设。
Pers Soc Psychol Rev. 1998;2(3):196-217. doi: 10.1207/s15327957pspr0203_4.
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