Banzi Rita, Bertele' Vittorio, Demotes-Mainard Jacques, Garattini Silvio, Gluud Christian, Kubiak Christine, Ohmann Christian
IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, via Giuseppe La Masa 19, 20156 Milano, Italy.
IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, via Giuseppe La Masa 19, 20156 Milano, Italy.
Eur J Intern Med. 2014 Oct;25(8):681-4. doi: 10.1016/j.ejim.2014.07.012. Epub 2014 Sep 6.
The European Medicines Agency has opened a window to access clinical trial data. This is an important step forward which deserves attention, support, and advice from all the stakeholders. Regulatory agencies are the most comprehensive repositories of clinical trial data on drugs and can also promote and develop standard practices for data sharing. The release of the EMA draft policy on publication and access to clinical trial data in 2013 has fueled a lively debate among academia, industry, and the public in general that is still ongoing. As clinical researchers and producers and users of clinical trial data, we endorse the European Medicines Agency's opening and offer a few suggestions for complete, safe, and effective data sharing.
欧洲药品管理局已开启了获取临床试验数据的窗口。这是向前迈出的重要一步，值得所有利益相关者予以关注、支持并提供建议。监管机构是有关药物临床试验数据最全面的储存库，还能够促进并制定数据共享的标准做法。2013年欧洲药品管理局发布的关于临床试验数据公布和获取的政策草案在学术界、产业界以及广大公众中引发了一场仍在持续的热烈辩论。作为临床研究人员以及临床试验数据的生产者和使用者，我们赞同欧洲药品管理局的这一开放举措，并就完整、安全且有效地进行数据共享提出几点建议。
