EMA “look, but don’t touch” terms of use for clinical study data are impracticable, says IQWiG
The German Institute for Quality and Efficiency in Health Care (IQWiG) has taken issue with plans announced by the European Medicines Agency for access to full clinical trial data, aiming to increase transparency.
The EMA receives comprehensive clinical study data from drug manufacturers. These data form the basis for the decision on the approval of new drugs. To make this information available to researchers and decision-makers, the EMA issued a draft policy in 2013 for the publication of clinical study data, in which extensive data transparency was planned.
Along with other interested parties, the IQWiG was intensely involved in the subsequent consultations. The result of these consultations is all the more disappointing; in particular the draft on the conditions of use for the EMA interface via which anyone should be able to access the data, says IQWiG.
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