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Volume 22, Issue 4 - Good Pharma

Regulatory Writing

Abstract

The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports included in a common technical document submission, along with the accompanying summary documents and overview. The varied stakeholders (pharmaceutical companies, patients) will have different opinions on the draft. The European Federation of Pharmaceutical Industries and Associations, a major representative of the pharmaceutical industry, have been particularly critical. While greater transparency is to be welcomed, inappropriate analyses of the data causing unwarranted public alarm and identification of anonymised information remain major concerns.

References

  1. Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. Trials 2010;11:9. Available from: http://dx.doi.org/10.1186/1745-6215-11-9
  2. Steinbrook R. The European Medicines Agency and the brave new world of access to clinical trial data. JAMA Intern Med 2013;173(5):373–4. Available from: http://dx.doi.org/10.1001/jamainternmed.2013.3842

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In the Bookstores
Journal Watch
The Webscout
Regulatory Writing
Medical Communications
Manuscript Writing
Out On Our Own
Erratum
The Light Stuff

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  • Victoria White (Tampa, Florida, USA)
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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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