European Medicines Agency responds to criticism over clinical trial reporting

News 06/06/2011

The European Medicines Agency has responded to an article published in the British Medical Journal (BMJ) that called for better reporting of the outcome of clinical trials in European public assessment reports (EPARs), by welcoming the feedback provided.

The Agency's letter, which was published on the BMJ's website on Wednesday 1 June, explains that transparency of its scientific discussions has been a priority since the Agency's establishment in 1995. The Agency recognises its unique role as an independent provider of information and works closely with its stakeholders to improve the structure and content of its information on medicines. It remains open to and grateful for suggestions on how to improve this further.

The letter points out that almost 700 EPARs are available on the Agency's website and that these are updated throughout the medicine's life. Each EPAR summarises the grounds for the Agency's opinion in favour of granting or refusing the marketing authorisation for a medicine, and results from the review of data supplied by the applicant and discussions during committee meetings. This information can now be complemented by information in the recently launched European Union Clinical Trials Register.

The letter emphasises the fact that medicine manufacturers have a legal obligation to submit the results of all clinical studies that may have an impact on a medicine's benefit-risk balance to the Agency. In line with the new policy on access to documents, the Agency is now releasing, on request, the full clinical trial reports submitted to it.

The letter, signed by the Agency's acting Executive Director, responded to the article EMA must improve the quality of its clinical trial reports by Corrado Barbui and colleagues, published online on Wednesday 25 May.

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