The European Medicines Agency (EMA) has become the first global medicines regulator to publish the clinical study reports (CSR) it receives from companies applying for market authorisation. The decision to publish CSRs was first outlined by the agency in April 2012 and the new policy came into effect on 1st January 2015. Since this date, companies making applications to the EMA must provide the supporting clinical data for publication on the EMA Clinical Data website, regardless of the outcome of the regulatory procedure. It was announced this week that the first reports have been released, providing around 260,000 pages of information for two medicines, Kyprolis® (for multiple myeloma) and Zurampic® (for gout).
The move, which is welcomed by many groups and organisations, including AllTrials, the BMJ, and NICE, aims to improve transparency and allow greater scrutiny of clinical trial data. It also aims to facilitate independent re-analysis of the data post-approval, improve scientific knowledge and drive innovation.
However, the policy has been challenged by several pharma companies, which has led to delays in its introduction and compromises regarding which data are released. Concerns that the policy only applies to new or modified applications have also been raised. Nonetheless, this policy is a major shift towards increased transparency, and it is hoped other regulatory agencies will follow where the EMA have dared to tread.
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Summary by Alice Wareham, PhD from Aspire Scientific
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