International Clinical Trials Day: 20 May 2013

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International Clinical Trials Day: 20 May 2013

The European Medicines Agency supports International Clinical Trials Day, which is taking place on Monday 20 May 2013.

International Clinical Trials Day was initiated by the European Clinical Research Infrastructures Network (ECRIN) to enhance communication and coordination of clinical research between countries and better meet the needs of patients globally. It is celebrated every year on or around 20 May, commemorating the day on which James Lind started his famous trial comparing treatments for scurvy on 20 May 1747.

The majority of the Agency's scientific work relies on clinical trials. The Agency’s scientific evaluation work involves the review of clinical-trial data that are included in marketing-authorisation applications submitted by pharmaceutical companies.

The Agency also provides scientific advice on the design of clinical trials conducted as part of medicine development and has a central role in ensuring application of good clinical practice (GCP) at a European Union (EU) level.

Proactive access to clinical-trial data

The Agency has been releasing clinical-trial data submitted as part of applications for marketing authorisation on request since November 2010, when it published its new policy on access to documents.

It is now working towards development of a policy for the proactive publication of data from clinical trials supporting the authorisation of medicines once a final outcome has been reached. The Agency believes that the release of data is ultimately about establishing trust and confidence in the system, as it allows scrutiny of the Agency’s recommendations on medicines.

The Agency is taking a considered, dialogue-based approach in designing this policy, respecting the views and concerns brought forward by all of its stakeholders.

A number of court cases are currently ongoing, which are challenging the Agency’s decisions to grant access to non-clinical and clinical information, including clinical-study reports, submitted by companies as part of marketing-authorisation applications in accordance with its 2010 access-to-documents policy.

Following the interim decisions of the General Court of the European Union ordering the Agency not to release documents in two specific cases, the Agency will continue with its policy to grant access to documents. However, requests for access to documents similar to those contested at the Court are being considered on a case-by-case basis.

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