Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
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DOI：
10.1002/pds.3281
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发表时间：
2012-07-01
影响因子：
2.6
通讯作者：
Fitt, Henry
中科院分区：
文献类型：
--
作者：
Blake, Kevin V.;deVries, Corinne S.;Fitt, Henry
目的 欧洲药物流行病学和药物警戒中心网络 (ENCePP) 是由欧洲药品管理局协调的一项举措，旨在建设授权后研究的能力并增加对授权后研究的信任，以进一步支持医学决策。方法 ENCePP 力求基于稳健的方法、透明度和科学独立性，在整个授权后研究过程中促进和支持高标准。结果 ENCePP 为工业界、学术界和监管机构的研究人员提供了一个接触点，寻求合作进行授权后研究。截至 2011 年 11 月 30 日，该网络由 98 个研究中心、13 个网络和 18 个数据源组成，其中大部分是学术和公共资助机构，但也有数据源提供商和具有开展授权后研究专业知识的合同研究组织。所有内容都列在免费、公共且可完全搜索的电子研究资源数据库中。已出版关于方法标准的指南和清单；引入了 ENCePP 研究的概念，包括行为准则；并推出了电子研究登记册。结论 预计 ENCePP 研究概念的应用将提高对药物授权后研究的信任度。研究登记册将允许随时获取研究方案和结果，从而提高透明度并促进审查。通过网络、标准、透明度和清晰的关系，ENCePP 预计将增强欧盟进行强有力的授权后研究的能力，从而有益于公众健康。版权所有 (c) 2012 John Wiley & Sons, Ltd.
Purpose The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), an initiative coordinated by the European Medicines Agency, aims to build capacity for and increase trust in post-authorisation studies to further support medicine decision making. Methods ENCePP seeks to promote and support high standards throughout the post-authorisation research process based on robust methodologies, transparency and scientific independence. Results ENCePP provides a point of access to researchers for industry, academia and regulatory authorities seeking collaboration for the conduct of post-authorisation studies. As of 30 November 2011, the network consisted of 98 research centres, 13 networks and 18 data sources, mostly academic and publicly funded institutions but also data source providers and contract research organisations with expertise in the conduct of post-authorisation studies. All are listed in the free, public and fully searchable electronic Database of Research Resources. A guide and a checklist on methodological standards have been published; the concept of an ENCePP study, including a Code of Conduct, introduced; and an electronic register of studies have been launched. Conclusion It is envisaged that application of the ENCePP study concept will result in an increase in trust in post-authorisation studies of medicines. The register of studies will allow for ready access to study protocols and results, thereby enhancing transparency and facilitating review. Through the network, standards, transparency and clarity of relationships, ENCePP is expected to add to the European Union capacity to conduct robust post-authorisation studies, thereby benefiting public health. Copyright (c) 2012 John Wiley & Sons, Ltd.