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October 25, 2016
The European Medicines Agency (EMA) has adopted a new policy to give open access to clinical reports for new medicines for human use authorized in the European Union (EU).
For every new medicine, citizens, including researchers and academics, will be able to directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of marketing authorization applications. These reports include information on the methods used and results of clinical trials. EMA claims to be the first regulatory authority worldwide to provide such broad access to clinical data.
"Transparency is an essential component in clinical research. Its outcome – whether positive or negative – should be made publicly available,” said Vytenis Andriukaitis, European Commissioner for Health and Food Safety. “EMA's transparency initiative will make Europe a true front runner with respect to release of data concerning clinical trials. It will create a bridge from now until the new Clinical Trials Regulation - which foresees additional milestones towards transparency."
This proactive approach means patients and healthcare professionals will be able to find out more information about the data underpinning the approval of medicines they are taking or prescribing, and it will also facilitate the independent re-analysis of data by academics and researchers after a medicine has been approved, according to an EMA statement issued on October 20.
“Transparency on clinical data is a longstanding commitment from EMA and today, we are delivering on our promise to give access to the data on which our recommendations are based”, explained the agency’s Executive Director Guido Rasi. “Our initiative has shaped the global debate towards more transparency. It will benefit academic research and the practice of medicine as a whole.”
EMA hopes increased transparency will also benefit innovation. “Patients and clinicians have been waiting a long time for clinical trial data. This new approach will at last provide transparent information on all results of clinical trials, positive or negative, as submitted to the EMA,” commented Yann Le Cam, CEO of EURORDIS-Rare Diseases Europe and member of the EMA’s Management Board. “We expect this to enhance trust in the medicines approval system. Access to this new knowledge base can help to accelerate innovation by reducing duplication of research and de-risking some new developments.”
Web access to data
The website, available at https://clinicaldata.ema.europa.eu, will include the clinical reports contained in all initial marketing authorization applications submitted on or after the policy took effect on January 1, 2015. The policy also applies to applications submitted on or after July 1, 2015 to vary a marketing authorization for an extension or modification of indication or a line extension.
EMA already has published data for two medicines, representing approximately 260,000 pages of information for over 100 clinical reports. Data will be progressively added online for all applications concerned since the policy came into force. Eventually EMA aims to publish the reports 60 days after a decision on an application has been taken, or within 150 days after the receipt of the withdrawal letter. It expects to offer access to approximately 4,500 clinical reports per year.