EMA should remove barriers to access clinical trial data

Carl Heneghan

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EMA should remove barriers to access clinical trial data

机译：EMA应消除访问临床试验数据的障碍

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Hundreds of supporters of the AilTrials campaign (alltrials.net) contributed lastyeartothe European Medicines Agency's consultation on its draft policy "Publication and access to clinical-trial data." We welcomed the EMA's proposals, which would have seen clinical study reports published proactively and openly, in line with an agency policy thatthe information in those reports should not generally be considered commercially confidential. We are now concerned thatthe most recent draft of the policy (EMA/240810/2013), as shared with some stakeholders at meetings this month, introduces barriers that will make it all but useless to independent researchers.

机译：数以百计的AILTRIALS运动支持者（Alltrials.net）为欧洲药品局就其政策草案“出版和获取临床审判数据的访问”贡献了最后的欧洲药品咨询。我们欢迎EMA的提案，该提案本来可以看到临床研究报告，并公开发布，这与代理机构政策一致，即这些报告中的信息通常不应被视为商业上的机密。我们现在担心该政策的最新草案（EMA/240810/2013）与本月会议上的一些利益相关者共享，引入了障碍，这将使独立研究人员几乎无用。

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来源
《BMJ: British medical journal》 |2014年第7962期|25-25|共1页
作者
Carl Heneghan;
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作者单位

Centre for Evidence based Medicine, Oxford;

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原文格式 PDF
正文语种英语
中图分类
关键词
Sketches; Clinical Trial; reportingPolicies;

机译：草图;临床试验;报告策略;

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EMA should remove barriers to access clinical trial data

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