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.
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