“医学透明”大潮在欧掀起——欧洲首度公开药企大量临床研究报告

2017-01-08 刘润生 刘润生博客

病人和临床医师长期呼吁让药企公开临床实验数据,提高药品研究与监管的透明度。在All Trials运动的支持下,约700个医患组织举行游说活动,要求公开所有临床研究报告。 在推动医学透明的一项里程碑性运动中,欧洲药品管理局开始公布从制药公司收到的全部临床研究数据的详细情况。根据该局2014年通过的临床研究报告公开政策,当制药公司申请欧洲药品管理局批准其在欧盟销售公司产品时,欧洲药品管理局

病人和临床医师长期呼吁让药企公开临床实验数据,提高药品研究与监管的透明度。在All Trials运动的支持下,约700个医患组织举行游说活动,要求公开所有临床研究报告。

在推动医学透明的一项里程碑性运动中,欧洲药品管理局开始公布从制药公司收到的全部临床研究数据的详细情况。根据该局2014年通过的临床研究报告公开政策,当制药公司申请欧洲药品管理局批准其在欧盟销售公司产品时,欧洲药品管理局会在网上公布该产品的全部临床研究结果。

2016年10月20日,欧洲药品管理局公布了一种癌症药和一种痛风药的约100份、共计26万页的临床研究报告。此举使欧洲药品管理局成为全球首个公开临床研究结果的重要药品监管机构。这些临床研究报告的内容比制药公司发表的期刊论文更为详细,而研究论文中的新药信息并不完整。临床研究报告的内容不仅包括药物的正面效果和负作用,还包括负作用的详细情况。

欧洲药品管理局执行主席吉多·拉西指出,该局2014年通过的这项临床研究报告公开政策不仅让学术研究受益,也会给医药界带来好处;不仅让学者在药物获得批准之后能独立地进行数据再分析,也能让其他制药公司借鉴他人经验。

根据计划,欧洲药品管理局将发布2015年1月1日以后向其申办新药审批的药品临床研究报告信息,不管这些申请是获批、被拒还是由公司撤回的。欧洲药品管理局一旦处理完所有积压任务,就会计划每年向公众公开4500份临床研究报告。它会编辑临床研究报告中的一些商业机密信息,并从编辑患者个体数据开始。在2016年10月20日发布的26万页报告中,几乎所有的编辑之处都是为了使患者数据匿名化;仅有两页的编辑是出于保护商业机密。欧洲药品管理局还表示,一旦与制药公司和其他利益相方就如何保护患者隐私达成协议,它会在遵守欧盟数据保护条例的情况下,公布患者个体数据。

在英国慈善团体“科学智识”领导All Trials临床试验数据公开运动的西莱·拉内呼吁,希望国际上的其他药品监管机构都能够以欧洲药品管理局为榜样。All Tirals运动在美国的领头人艾谱莉·克利本谢林称,欧洲药品管理局的临床数据公开政策为美国医学界树立了榜样。目前,美国食品药品管理局批准一项药物时还不会发布该药物的临床研究报告结果。

不过,欧洲药品管理局面临的考验是制药公司会以保护商业机密为由阻止公开临床实验数据。以前,根据欧洲药品管理局2010年采用的条例,欧洲药品管理局仅在第三方行使信息自由请求时,才会向第三方发布某些数据。即便如此,这还是导致一些制药公司起诉欧洲药品管理局,欲以商业机密为由禁止其公开自己的产品信息数据。在2016年7月的诉讼中,欧盟法院就发出临时司法禁令,禁止欧洲药品管理局公开Bravecto兽用药毒性研究和杜氏肌肉营养不良治疗药物Translarna的临床研究报告。两家制药公司均辩护称,如果欧洲药品管理局公开信息,就会侵犯它们的商业机密保护权利。2016年9月29日,欧洲药品管理局已对法院的这两项决定提出上诉。

MedSci是中国为数不多支持并推动ALL Trials在全球发展的机构之一。

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    2017-01-15 虈亣靌

    学习了,收藏了

    0

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    2017-01-09 1e10c84am36(暂无匿称)

    文章很好,拜读受益

    0

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    2017-01-09 yamasheep

    那么厚的东西,谁有耐心看

    0

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    2017-01-09 CHBLY

    支持公开

    0

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    2017-01-09 刘煜

    阅读了谢谢分享

    0

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    2017-01-08 知难而进

    谢谢分享!!!!!!

    0

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    2017-01-08 1e184d7bm65(暂无匿称)

    棒棒哒???????

    0

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