EMA：欧洲临床试验登记网开始正式上线

EU Clinical Trials Register goes live
Public online register gives access to information on clinical trials

The EU Clinical Trials Register (https://www.clinicaltrialsregister.eu/) was launched today by the European Medicines Agency (EMA). The online register gives for the first time public access to information on interventional clinical trials for medicines authorised in the 27 EU Member States and Iceland, Liechtenstein and Norway. The database also allows the public to search for information on clinical trials authorised to be carried out outside the EU if these trials are part of a paediatric investigation plan.
- E; D- G+ i( l$ G; y) Q
The information contained in the EU Clinical Trials Register is extracted from EudraCT, the EU clinical trials database. It is provided by the sponsor of the clinical trial, and is a component of its application to a national medicines regulatory authority for authorisation to conduct a trial. The information from the sponsor is loaded into the EudraCT database by the national medicines regulatory authority. The authority adds to this information the authorisation of the clinical trial and the opinion from the relevant ethics committee. Information on third-country trials that are listed in a paediatric investigation plan (PIP) is provided by the PIP addressee directly, via the EMA, to the system.
6 e& {, L7 f. z5 [
8 H9 e1 B$ h8 n" e- O# KThroughout the project the Agency worked together with stakeholders, including patients and healthcare professionals, to ensure that their needs were taken into account, to the extent possible at this stage, when designing the register.
2 X& n; M& I2 u: ^# I6 X' `
Lise Murphy, co-chair of the Agency’s Working Party with Patients’ and Consumers’ Organisations said:”We welcome the launch of the EU Clinical Trials Register. It increases transparency of medical research and will make it much easier for patients to find information about clinical trials taking place in Europe. We are committed to continue working with the EMA to further develop the system so that it becomes a valuable and useful resource for patients across the EU.”
7 D- T3 a7 H. P
The Agency will continue to work with stakeholders to improve the functioning of the EU Clinical Trials Register, in particular by enhancing the quality and completeness of data, and improving the search functionality. Plans for the future also include the publication of summaries of clinical trial results, on which draft guidance has already been published for consultation by the European Commission. Publication of trial results summaries will require a major upgrade to the existing system, the start of which will depend on finalisation of the guideline and availability of budget and resources.

1 z7 {* N3 z+ s8 W5 y% {Notes
& E/ R; M7 B, {6 m8 i
The clinical trials register is part of EudraPharm, the Community database of authorised medicinal products.
: t& B7 i: m- K; D9 ]( y2 cThe data in the EU clinical trials register are extracted from EudraCT, the EU clinical trials database.
; l# h& J; |$ }0 nSee the draft implementing technical guidance - List of fields for result-related information to be submitted to the 'EudraCT' clinical trials database, and to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41 of Regulation (EC) No 1901/2006 and their implementing guidelines 2008/C168/02 and 2009/C28/01.
The approval of clinical trials applications in the EU is the responsibility of the Member States. See more information on clinical trials in the EU.
& {5 v8 K" ^# W7 t8 g) n
http://www.ema.europa.eu/ema/ind ... &jsenabled=true


9 C" W6 q6 l: Z5 g2 N1 m" E

( J  g4 }! v/ r( s欧盟临床试验登记网今日上线
# V. X3 D1 p& L开放性在线登记使公众了解临床试验信息
5 d. n0 k% y! s" J& h
& x7 N! l5 r: w+ F$ b( Y欧盟临床试验登记网(https://www.clinicaltrialsregister.eu/)今日由欧洲药管局（EMA）启动上线。该网站实行在线登记方式，使公众首次能了解欧盟27个成员国以及冰岛、列支敦斯登和挪威这些国家开展的干预性药物临床试验的信息，公众还可以了解到药物儿科研究计划中在欧洲本土之外进行的药物临床试验的信息。

欧盟临床试验登记网所含信息来源于欧洲临床试验数据库(EudraCT)。按照成员国临床试验申请方面的要求，委托方负责提交这些临床试验信息。相关国家的药品管理部门将这些临床试验信息输入欧洲临床试验数据库，同时补充这些临床试验获得许可以及相关伦理委员会意见信息。对于儿科研究计划中在第三国（译者注：以上27+3个成员国之外的国家）开展的临床试验的信息，由儿科研究计划联系人通过欧洲药管局直接输入欧洲临床试验数据库。
- @' q. n1 A6 S6 ~" B/ L- o: z
/ f3 Y9 o, y0 r" e在欧盟临床试验登记网的设计过程中，欧洲药管局始终和包括患者和医护人员在内的利害关系方保持通力合作，确保在目前阶段条件能允许的范围内充分考虑他们的需求。

欧洲药管局患者与消费者工作小组共同主席Lise Murphy评论说：“我们欢迎欧盟临床试验登记网上线，它增加了临床研究的透明度，也让患者能比较容易能了解在欧洲进行的临床试验的相关信息。我们会继续与欧洲药管局一起继续发展这个系统，让它成为对所有欧洲患者都很重要和有用的信息资源”。
% ]2 }. A4 \6 R6 p
欧洲药管局会继续和利害关系方一起合作，努力提高欧盟临床试验登记网的功能，尤其是提高数据的质量和完整度并改善网站搜索功能。由于需要对现有的系统进行升级才能支持在网站公布相关临床试验的结果总结，因此结果公开的开始时间将取决于相关指南定稿以及相关预算/资源到位的时间。

备注
4 r6 L3 j$ s% ~1 e9 Y
欧盟临床试验登记网是欧盟获批药品数据库(EudraPharmfile:///C:/DOCUME~1/qijian.luo/LOCALS~1/Temp/msohtmlclip1/01/clip_image001.gif)的一部分。
% n( S% H. Q# c: Z: P& |欧盟临床试验登记网的信息来源于欧盟临床试验数据库(EudraCTfile:///C:/DOCUME~1/qijian.luo/LOCALS~1/Temp/msohtmlclip1/01/clip_image001.gif)
浏览“实施技术指南草案—按照欧盟法规(EC) No 726/2004第57(2)款、(EC) No 1901/2006第41款以及实施指南2008/C168/02 和2009/C28/01的要求，需提交至欧盟临床试验数据库(EudraCT)并进行公开的结果相关信息”（draft implementing technical guidance - List of fields for result-related information to be submitted to the 'EudraCT' clinical trials database, and to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41 of Regulation (EC) No 1901/2006 and their implementing guidelines 2008/C168/02 and 2009/C28/01file:///C:/DOCUME~1/qijian.luo/LOCALS~1/Temp/msohtmlclip1/01/clip_image001.gif）
  F1 r5 d* \& N各个成员国负责临床试验申请的批准，更多信息请浏览clinical trials in the EUfile:///C:/DOCUME~1/qijian.luo/LOCALS~1/Temp/msohtmlclip1/01/clip_image001.gif。
" @7 W: F8 ~* E! t/ p, O" ?

) M% J; c, @$ M