EMA moves forward with clinical trial data debate
The European Medicines Agency (EMA) is moving forward with the debate over transparency and publication of data from clinical studies. The EMA has announced that it “will proactively publish clinical trial data and enable access to full data sets by interested parties”, but that “a number of practical and policy issues need to be addressed” first.
The EMA has arranged a workshop on 22nd November 2012, in order to listen to the views, interest and concerns from a broad range of institutions, groups and individuals. The EMA believes that the discussions raised in this workshop will help it to “define the modalities of proactive access to clinical trial data, in a way that best serves patients and public health in an open and transparent forum”.
Some of the issues expected to be addressed at the workshop include the different levels of access to data, patient confidentiality and the conditions needed when sharing data to third parties.
EMA workshop to explore trial data publication (Pharma Times)
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