The European Clinical Trials Directive

 2 Feb 2004

The Genetics Interest Group reports a worrying development for the future of European clinical trials for charity-funded research. Alastair Kent, Director of GIG writes:

"Dear Colleagues,

The European Clinical Trials Directive is about to be put into effect. Designed to raise standards and improve the quality of clinical trials it creates a new regulatory framework for the conduct of trials. Aimed at large scale trials conducted by big pharmaceutical companies the administrative impact of the Directive will have a disproportionate impact on patient focussed trials conducted by universities and hospitals using funding from charities and patient groups. These trials have generated many benefits for patients - especially those with rare disorders or who need therapies that do not involve drug treatment. It is essential that these trials can continue.

A petition to the European Parliament is being organised by researchers, directors and patient groups. This petition aims to alter or repeal the Directive before non-commercial clinical trials are forced out of existence in Europe.

Information about the campaign and the petition to the European Parliament can be found on www.saveeuropeanresearch.org

Please visit this website, read the information and sign the petition, either as an individual or on behalf of your group if you can. Even if clinical trials are a long way off for the disorders you are interested in they will be needed one day. We need to make sure that, when this happens the regulatory framework helps to make this happen rather than actively preventing it. "

How to Help

Please visit www.saveeuropeanresearch.org and add your name to the petition. As a member of the JTSMA, enter 'JTSMA' for the institution and 'member' for position.

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