How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.
How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice.
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DOI：
10.1111/bcp.13023
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发表时间：
2016-10
影响因子：
3.4
通讯作者：
Vamvakas S
中科院分区：
文献类型：
--
作者：
Tafuri G;Pagnini M;Moseley J;Massari M;Petavy F;Behring A;Catalan A;Gajraj E;Hedberg N;Obach M;Osipenko L;Russo P;Van De Casteele M;Zebedin EM;Rasi G;Vamvakas S
2010年，欧洲药品管理局（EMA）启动了一个与卫生技术评估机构（HTAB）平行科学建议的试点项目，该项目允许制造商同时收到欧盟（EU）监管机构和HTAB对其药物开发计划的反馈。本回顾性定性分析旨在探讨平行科学建议系统如何工作，以及欧盟监管机构和HTAB之间以及HTAB之间的共性水平，当申请人从监管和HTA角度获得平行科学建议时。我们分析了EMA在2010年（当时推出了平行建议）和2015年5月1日（当时设定了数据提取的截止日期）之间举行的讨论会议的记录。该分析基于预先确定的标准，并在两个不同的比较层面进行：HTAB的答案与监管机构的答案，以及参与HTA机构的答案之间的比较。该分析基于31个平行科学建议程序。关于患者人群的问题的完全同意率最高（77%），而关于对照研究的问题的不同意率达到最高（30%）。关于HTAB之间的比较，所有领域都有很高的一致性。在临床开发的大多数方面，欧盟监管机构和参与HTAB之间以及HTAB之间在证据要求方面存在明显的共性。事实上，无论问题的内容如何，分析表明，通过并行的科学咨询过程，达成了高度的总体一致。
In 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the European Union (EU) regulators and HTABs on their development plans for medicines. The present retrospective qualitative analysis aimed to explore how the parallel scientific advice system is working and levels of commonality between the EU regulators and HTABs, and among HTABs, when applicants obtain parallel scientific advice from both a regulatory and an HTA perspective. We analysed the minutes of discussion meetings held at the EMA between 2010, when parallel advice was launched, and 1 May 2015, when the cutoff date for data extraction was set. The analysis was based on predefined criteria and conducted at two different levels of comparison: the answers of the HTABs vs. those of the regulators, and between the answers of the participating HTA agencies. The analysis was based on 31 procedures of parallel scientific advice. The level of full agreements was highest for questions on patient population (77%), while disagreements reached a peak for questions on the study comparator (30%). With regard to comparisons among HTABs, there was a high level of agreement for all domains. There is evident commonality, in terms of evidence requirements between the EU regulators and participating HTABs, as well as among HTABs, on most aspects of clinical development. Indeed, regardless of the question content, the analysis showed that a high level of overall agreement was reached through the process of parallel scientific advice.
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影响因子：
6.7
作者：
Eichler, H-G;Baird, L. G.;Hirsch, G.
通讯作者：
Hirsch, G.
影响因子：
2.8
作者：
Mathes T;Jacobs E;Morfeld JC;Pieper D
通讯作者：
Pieper D
DOI：
10.1017/s0266462308080343
发表时间：
2008-06-01
影响因子：
3.2
作者：
Drummond, Michael F.;Schwartz, J. Sanford;Sullivan, Sean D.
通讯作者：
Sullivan, Sean D.
影响因子：
50.5
作者：
Russo, P.;Mennini, F. S.;Rasi, G.
通讯作者：
Rasi, G.
DOI：
10.2147/dddt.s49935
发表时间：
2014
期刊：
Drug design, development and therapy
影响因子：
--
作者：
Ciani O;Jommi C
通讯作者：
Jommi C