Sharing clinical trial data on patient level: opportunities and challenges.
Sharing clinical trial data on patient level: opportunities and challenges.
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DOI：
10.1002/bimj.201300283
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发表时间：
2015-01
影响因子：
1.7
通讯作者：
Posch, Martin
中科院分区：
文献类型：
--
作者：
Koenig, Franz;Slattery, Jim;Groves, Trish;Lang, Thomas;Benjamini, Yoav;Day, Simon;Bauer, Peter;Posch, Martin
关键词：
近几个月来，监管机构、制药行业、期刊编辑和学术界讨论的最具争议性的话题之一是患者级临床试验数据的共享。多个项目已经启动，例如欧洲药品管理局 (EMA) 的“主动发布临床试验数据”、BMJ 开放数据活动或 AllTrials 计划。 EMA 执行主任 Guido Rasi 博士最近宣布，将从 2014 年起公布患者水平的临床试验数据（尽管此后已被推迟）。 EMA 关于主动获取临床试验数据的政策草案于 2013 年 6 月底发布，并在 2013 年 9 月底之前开放公众咨询。这些举措将改变药物开发和医学研究出版的格局。它们为研究和研究综合提供了前所未有的机会，但也给监管机构、赞助商、科学期刊和公众带来了新的挑战。除了这些一般方面之外，数据共享还涉及复杂的生物统计问题，例如多重性问题。这方面的一个重要问题是对前瞻性和回顾性多项统计分析的解释。需要生物统计学方面的专业知识来评估对此类多重分析的解释，例如，在监管决策的背景下，通过优化程序指导和复杂的分析方法。
In recent months one of the most controversially discussed topics among regulatory agencies, the pharmaceutical industry, journal editors, and academia has been the sharing of patient-level clinical trial data. Several projects have been started such as the European Medicines Agency´s (EMA) “proactive publication of clinical trial data”, the BMJ open data campaign, or the AllTrials initiative. The executive director of the EMA, Dr. Guido Rasi, has recently announced that clinical trial data on patient level will be published from 2014 onwards (although it has since been delayed). The EMA draft policy on proactive access to clinical trial data was published at the end of June 2013 and open for public consultation until the end of September 2013. These initiatives will change the landscape of drug development and publication of medical research. They provide unprecedented opportunities for research and research synthesis, but pose new challenges for regulatory authorities, sponsors, scientific journals, and the public. Besides these general aspects, data sharing also entails intricate biostatistical questions such as problems of multiplicity. An important issue in this respect is the interpretation of multiple statistical analyses, both prospective and retrospective. Expertise in biostatistics is needed to assess the interpretation of such multiple analyses, for example, in the context of regulatory decision-making by optimizing procedural guidance and sophisticated analysis methods.
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DOI：
10.1136/bmj.f6104
发表时间：
2013-10-29
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Jones CW;Handler L;Crowell KE;Keil LG;Weaver MA;Platts-Mills TF
通讯作者：
Platts-Mills TF
DOI：
10.1111/rssb.12048
发表时间：
2014-09-01
影响因子：
5.8
作者：
Aharoni, Ehud;Rosset, Saharon
通讯作者：
Rosset, Saharon
DOI：
10.1111/rssb.12028
发表时间：
2014-01-01
影响因子：
5.8
作者：
Benjamini, Yoav;Bogomolov, Marina
通讯作者：
Bogomolov, Marina
影响因子：
4.2
作者：
Alvarez, Yolanda;Hidalgo, Ana;Slattery, Jim
通讯作者：
Slattery, Jim
影响因子：
1.8
作者：
Eichler, Hans-Georg;Hemmings, Robert J.;Vamvakas, Spiros
通讯作者：
Vamvakas, Spiros