Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight
Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight
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DOI：
10.1111/bcp.13165
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发表时间：
2017-04-01
影响因子：
3.4
通讯作者：
Dreyer, Nancy Ann
中科院分区：
文献类型：
--
作者：
Engel, Pierre;Almas, Mariana Ferreira;Dreyer, Nancy Ann
AimsTo描述和表征的第一批授权后安全性研究（PASS）协议审查根据最近的欧洲pharmacovigilationlegislation.MethodsA系统的方法被用来编译所有公开可用的信息PASS协议和评估提交2012年7月至2015年7月从药物警戒风险评估委员会（PRAC）会议记录，欧洲药品管理局（EMA）和欧洲药物警戒和药物流行病学网络（ENCePP）的网页。结果在研究期间，189个不同的PASS协议提交给PRAC，截至2015年7月，其中一半已录入ENCePP许可后研究电子注册表（EU-PAS）。在353次PRAC审查期间对这些方案进行了评估。EMA仅发布了31%的PRAC反馈，其中主要关注的是研究设计（37%）和可行性（30%）。在189例PASS中，略多涉及原始数据采集（58%）。PASS评估药物利用主要利用二级数据源（58%）。大多数的PASS不包括一个比较器（65%）和35%的PASS还评估了临床有效性endpoints.ConclusionsTo最好的我们所知，这是第一次全面审查三年的PASS协议下提交的新的药物警戒立法。我们的研究结果表明，EMA和PASS申办者可以分别增加EU-PAS中的方案评估和文件的可用性。方案内容审查和大量与方法学问题和可行性问题相关的PRAC评论应提高PASS利益相关者的认识，以根据药物流行病学原则和现有指南设计更周到的研究。
AimsTo describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation.MethodsA systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages.ResultsDuring the study period, 189 different PASS protocols were submitted to the PRAC, half of which were entered in the ENCePP electronic register of post-authorization studies (EU-PAS) by July 2015. Those protocols were assessed during 353 PRAC reviews. The EMA published only 31% of the PRAC feedback, of which the main concerns were study design (37%) and feasibility (30%). Among the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints.ConclusionsTo the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines.