Fostering EMA's transparency policy

Rita Banzi, Vittorio Bertele', Jacques Demotes-Mainard, Silvio Garattini, Christian Gluud, Christine Kubiak, Christian Ohmann

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)681-684
Number of pages4
JournalEuropean Journal of Internal Medicine
Volume25
Issue number8
DOIs
Publication statusPublished - Oct 1 2014

Keywords

  • Clinical trials
  • Drug regulation
  • Ethics
  • Independent clinical research
  • Individual-patient data
  • Transparency

ASJC Scopus subject areas

  • Internal Medicine
  • Medicine(all)

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