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对提交至《试验》杂志的方案的评审与发表——我们在十年中学到了什么?

Review and publication of protocol submissions to Trials - what have we learned in 10 years?

作者信息

Li Tianjing, Boutron Isabelle, Al-Shahi Salman Rustam, Cobo Erik, Flemyng Ella, Grimshaw Jeremy M, Altman Douglas G

机构信息

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Room E6011, Baltimore, MD, 21205, USA.

University Paris Descartes, Inserm Methods Team, CRESS-UMR 1153, Paris, France.

出版信息

Trials. 2016 Dec 16;18(1):34. doi: 10.1186/s13063-016-1743-0.

DOI:10.1186/s13063-016-1743-0
PMID:28114958
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5256548/
Abstract

Trials has 10 years of experience in providing open access publication of protocols for randomised controlled trials. In this editorial, the senior editors and editors-in-chief of Trials discuss editorial issues regarding managing trial protocol submissions, including the content and format of the protocol, timing of submission, approaches to tracking protocol amendments, and the purpose of peer reviewing a protocol submission. With the clarification and guidance provided, we hope we can make the process of publishing trial protocols more efficient and useful to trial investigators and readers.

摘要

《试验》在提供随机对照试验方案的开放获取出版方面拥有10年经验。在这篇社论中,《试验》的高级编辑和主编讨论了有关管理试验方案提交的编辑问题,包括方案的内容和格式、提交时间、跟踪方案修订的方法以及对方案提交进行同行评审的目的。通过提供的澄清和指导,我们希望能够使试验方案的出版过程对试验研究者和读者更高效且更有用。

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N Engl J Med. 2016 Nov 17;375(20):1998-2004. doi: 10.1056/NEJMsr1611785. Epub 2016 Sep 16.
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From protocol to published report: a study of consistency in the reporting of academic drug trials.从方案到发表报告:学术药物试验报告一致性的研究
Trials. 2016 Feb 19;17:100. doi: 10.1186/s13063-016-1189-4.
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J Clin Oncol. 2015 Nov 1;33(31):3583-90. doi: 10.1200/JCO.2015.62.4148. Epub 2015 Aug 24.
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SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.SPIRIT 2013 解释和说明:临床试验方案指南。
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