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The European Medicines Agency and the Brave New World of Access to Clinical Trial Data

The European Medicines Agency and the Brave New World of Access to Clinical Trial Data COMMENTARY The European Medicines Agency and the Brave New World of Access to Clinical Trial Data SOF JANUARY 2014, analysis plans etc)?” (4) good analy- pected to take effect in 2013, the the European Medi- sis practice; and (5) legal aspects, EMA will request that companies cines Agency (EMA) that is “are there any legal aspects and other sponsors of trials submit will publish clinical other than personal data protec- the raw data with full details in a for- A trial data for the tion that need to be addressed” and mat that can be analyzed. medications it considers for ap- “are there exceptional circum- In the European Union, citizens proval. After the marketing autho- stances under which data can be have extensive access to agency rization process is complete, re- claimed to be commercially confi- documents, subject to defined lim- searchers and others who are dential?” The EMA plans to re- its. In 2007, Danish researchers re- independent of the sponsors of stud- lease a draft policy by June 30, 2013, quested trial protocols and clinical ies, the authors of journal reports, accept public comments through study reports for 2 antiobesity and regulatory agencies should be September 30, http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

The European Medicines Agency and the Brave New World of Access to Clinical Trial Data

Steinbrook, Robert
JAMA Internal Medicine , Volume 173 (5) – Mar 11, 2013
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Publisher
American Medical Association
Copyright
Copyright 2013 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2013.3842
pmid
23599919
Publisher site
See Article on Publisher Site

Abstract

COMMENTARY The European Medicines Agency and the Brave New World of Access to Clinical Trial Data SOF JANUARY 2014, analysis plans etc)?” (4) good analy- pected to take effect in 2013, the the European Medi- sis practice; and (5) legal aspects, EMA will request that companies cines Agency (EMA) that is “are there any legal aspects and other sponsors of trials submit will publish clinical other than personal data protec- the raw data with full details in a for- A trial data for the tion that need to be addressed” and mat that can be analyzed. medications it considers for ap- “are there exceptional circum- In the European Union, citizens proval. After the marketing autho- stances under which data can be have extensive access to agency rization process is complete, re- claimed to be commercially confi- documents, subject to defined lim- searchers and others who are dential?” The EMA plans to re- its. In 2007, Danish researchers re- independent of the sponsors of stud- lease a draft policy by June 30, 2013, quested trial protocols and clinical ies, the authors of journal reports, accept public comments through study reports for 2 antiobesity and regulatory agencies should be September 30,

Journal

JAMA Internal Medicine – American Medical Association

Published: Mar 11, 2013

References

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    Rodwin, MA; Abramson, JD
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    Doshi, P; Jefferson, T
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