An analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules.-临床诊疗知识库

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To investigate the frequency of interim analyses, stopping rules, and data safety and monitoring boards (DSMBs) in protocols of randomized controlled trials (RCTs); to examine these features across different reasons for trial discontinuation; and to identify discrepancies in reporting between protocols and publications.We used data from a cohort of RCT protocols approved between 2000 and 2003 by six research ethics committees in Switzerland, Germany, and Canada.Of 894 RCT protocols, 289 prespecified interim analyses (32.3

作者：Mihaela, Stegert；Benjamin, Kasenda；Erik, von Elm；John J, You；Anette, Blümle；Yuki, Tomonaga；Ramon, Saccilotto；Alain, Amstutz；Theresa, Bengough；Matthias, Briel

来源：Journal of clinical epidemiology 2016 年 69卷

循证治疗系统评价与Meta分析随机对照研究队列研究

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An analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules.

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作者：

Mihaela, Stegert；Benjamin, Kasenda；Erik, von Elm；John J, You；Anette, Blümle；Yuki, Tomonaga；Ramon, Saccilotto；Alain, Amstutz；Theresa, Bengough；Matthias, Briel

来源：

Journal of clinical epidemiology 2016 年 69卷

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Data monitoring committees Early termination of clinical trials Interim analysis Protocol Randomized controlled trials Stopping Rules

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