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Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

, 1 , 2 , the ENCePP Steering Group

Pharmacoepidemiology and Drug Safety

John Wiley and Sons Inc.

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      Most cited references 18

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      Good practices for real‐world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR‐ISPE Special Task Force on real‐world evidence in health care decision making

      Abstract Purpose Real‐world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. Methods The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus‐building iterative process for the topics and framing of recommendations. Results The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. Conclusion The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.
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        The Innovative Medicines Initiative: an engine for regulatory science.

        Since its launch in 2008, the Innovative Medicines Initiative has catalysed the formation of many consortia to address challenges in drug development and regulation. As it moves into its second phase, we highlight key outcomes so far and the lessons learned.
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          Good Signal Detection Practices: Evidence from IMI PROTECT

          Over a period of 5 years, the Innovative Medicines Initiative PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) project has addressed key research questions relevant to the science of safety signal detection. The results of studies conducted into quantitative signal detection in spontaneous reporting, clinical trial and electronic health records databases are summarised and 39 recommendations have been formulated, many based on comparative analyses across a range of databases (e.g. regulatory, pharmaceutical company). The recommendations point to pragmatic steps that those working in the pharmacovigilance community can take to improve signal detection practices, whether in a national or international agency or in a pharmaceutical company setting. PROTECT has also pointed to areas of potentially fruitful future research and some areas where further effort is likely to yield less.
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            Author and article information

            Affiliations
            [ 1 ] Pharmacovigilance and Epidemiology Department European Medicines Agency London UK
            [ 2 ] Vice President and Global Head of Epidemiology, RTI‐HS Barcelona Spain
            Author notes
            [* ] Correspondence

            X. Kurz, Pharmacovigilance and Epidemiology Department, European Medicines Agency, London, UK.

            Email: xavier.kurz@ 123456ema.europa.eu

            [†]

            Members of the ENCePP Steering Group 2017 to 2019 include (in alphabetical order) Kathi Apostolidis, Peter Arlett (Chair 2009‐2016), Gianmario Candore, Marie L. De Bruin, Corinne de Vries, Dinah Duarte, Vera Ehrenstein, Hans‐Georg Eichler, Rosa Gini, Teresa Herdeiro, Johann L. Hillege, Olaf H. Klungel, Xavier Kurz (Chair), Herve Le Louet, Thomas M. MacDonald (Co‐Chair), Giampiero Mazzaglia, Yola Moride, Jim Slattery, Gianluca Trifirò, and Patrice Verpillat (EFPIA observer).

            Contributors
            ORCID: http://orcid.org/0000-0002-9838-7754, xavier.kurz@ema.europa.eu
            Journal
            Pharmacoepidemiol Drug Saf
            Pharmacoepidemiol Drug Saf
            10.1002/(ISSN)1099-1557
            PDS
            Pharmacoepidemiology and Drug Safety
            John Wiley and Sons Inc. (Hoboken )
            1053-8569
            1099-1557
            11 January 2018
            March 2018
            : 27
            : 3 ( doiID: 10.1002/pds.v27.3 )
            : 245-252
            29327451
            5873428
            10.1002/pds.4381
            PDS4381 PDS-17-0463.R1
            © 2018 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

            This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

            Counts
            Figures: 5, Tables: 3, Pages: 8, Words: 3717
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            Custom metadata
            2.0
            pds4381
            March 2018
            Converter:WILEY_ML3GV2_TO_NLMPMC version:version=5.3.3 mode:remove_FC converted:28.03.2018

            Pharmacology & Pharmaceutical medicine

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