Further discussion of the EU Clinical Trials Regulation in Europe

Posted on September 5, 2013 by

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We have supported a briefing for MEPs on the  EU Clinical Trials Regulation. The Regulation is going through the EU legislative process at the moment and is about to enter trilogue negotiations between MEPs, members states on the Council and the European Commission.

We joined 25 major UK research funders and academies across Europe to comment on the current proposals and flag our key priorities for the negotiations. These include clarifying which studies fall within the scope of the Regulation and welcoming measures to promote transparency while working to ensure these are achievable and proportionate.

Background

Clinical trials are an essential step in turning a discovery in a lab into a treatment for patients. New drugs must go through a series of controlled tests to ensure they are safe and effective. Clinical trials, involving healthy volunteers or patients, help us establish whether a drug is safe and how well it works. This POSTnote gives a great overview of clinical trials. 41 of our member charities are currently funding clinical trials either individually or in collaboration with industry, other charities or public funders.

Clinical trials across the EU are governed by the Clinical Trials Directive which was made in 2001.

However, there have been difficulties in implementing the regulations and concerns that they may actually be leading to unnecessary delays and escalating costs. The European Commission quotes a decrease of 25% of clinical trials conducted in the EU during the period between 2007 and 2011.

In response to this, the EU is revising the Directive. They consulted widely before publishing their proposals in a new Clinical Trials Regulation in July 2012 which is now making its way through the EU legislative process. It is expected that the new Regulation will be agreed early next year and implemented in 2016.

Posted in: Policy