Literature DB >> 25200801

Fostering EMA's transparency policy.

Rita Banzi1, Vittorio Bertele'2, Jacques Demotes-Mainard3, Silvio Garattini2, Christian Gluud4, Christine Kubiak3, Christian Ohmann5.   

Abstract

The European Medicines Agency has opened a window to access clinical trial data. This is an important step forward which deserves attention, support, and advice from all the stakeholders. Regulatory agencies are the most comprehensive repositories of clinical trial data on drugs and can also promote and develop standard practices for data sharing. The release of the EMA draft policy on publication and access to clinical trial data in 2013 has fueled a lively debate among academia, industry, and the public in general that is still ongoing. As clinical researchers and producers and users of clinical trial data, we endorse the European Medicines Agency's opening and offer a few suggestions for complete, safe, and effective data sharing.
Copyright © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Entities:  

Keywords:  Clinical trials; Drug regulation; Ethics; Independent clinical research; Individual-patient data; Transparency

Mesh:

Year:  2014        PMID: 25200801     DOI: 10.1016/j.ejim.2014.07.012

Source DB:  PubMed          Journal:  Eur J Intern Med        ISSN: 0953-6205            Impact factor:   4.487


  3 in total

1.  Sharing data from clinical trials: the rationale for a controlled access approach.

Authors:  Matthew R Sydes; Anthony L Johnson; Sarah K Meredith; Mary Rauchenberger; Annabelle South; Mahesh K B Parmar
Journal:  Trials       Date:  2015-03-23       Impact factor: 2.279

2.  Considerations for an integrated population health databank in Africa: lessons from global best practices.

Authors:  Jude O Igumbor; Edna N Bosire; Marta Vicente-Crespo; Ehimario U Igumbor; Uthman A Olalekan; Tobias F Chirwa; Sam M Kinyanjui; Catherine Kyobutungi; Sharon Fonn
Journal:  Wellcome Open Res       Date:  2021-08-23

3.  The evidence base for psychotropic drugs approved by the European Medicines Agency: a meta-assessment of all European Public Assessment Reports.

Authors:  Florian Erhel; Alexandre Scanff; Florian Naudet
Journal:  Epidemiol Psychiatr Sci       Date:  2020-04-27       Impact factor: 6.892

  3 in total

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