Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
| Autor: | Corinne S deVries, Xavier Kurz, Henry Fitt, Peter Arlett, Kevin Blake |
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| Rok vydání: | 2012 |
| Předmět: |
Epidemiology
business.industry media_common.quotation_subject Public relations Pharmacoepidemiology Transparency (behavior) Independence Checklist law.invention law Agency (sociology) Pharmacovigilance CLARITY media_common.cataloged_instance Medicine Pharmacology (medical) European union business media_common |
| Zdroj: | Pharmacoepidemiology and Drug Safety. 21:690-696 |
| ISSN: | 1053-8569 |
| DOI: | 10.1002/pds.3281 |
| Popis: | 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 © 2012 John Wiley & Sons, Ltd. |
| Databáze: | OpenAIRE |
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