European Clinical Research Legislation Under Review

London, United Kingdom (PressExposure) November 21, 2009 -- The European Union's 2001 Clinical Trials Directive has received a lot of negative press especially among clinical research organisations who want to focus on enhancing relationships between researchers, sponsors, stakeholders, authorities, ethics committees and patients and transform research results into tangible benefits for the medical associations across Europe.

In an article for Applied Clinical Trials Online, Peter O'Donnell writes about how clinical research companies and institutions have banded together to find solutions for the problems encountered in the directive, which they are hoping to have implemented in 2010. The project is called the "Road Map Initiative for Clinical Research in Europe" and consists of a number of workshops this year that will continue into early 2010.

One such workshop was held in London, UK, in September with co-sponsorship in as its theme. More specifically, it dealt with the requirement in the directive regarding a single sponsor's legal responsibility for all aspects of the clinical research project. According to workshop organisers, the demands placed on sponsors of international trials are such that many organisations shy away from sponsorship deals. Academic institutions are most affected by current sponsorship legislations as they are reluctant to take on the legal limitations, costs and risks of projects. The aim of the workshop was to find ways in which sponsors would be able to share responsibility for the management and financing of clinical trials.

Legislation governing pharmaceutical research and pharmacovigilance are also under review, particularly with regard to punitive measures against counterfeiting and allowing pharmaceutical companies to provide patients with more information regarding prescription medication. UK Socialist, Linda McAvan, has been appointed by the new EU Level pharmacovigilance committee to draft a report on pharmacovigilance. McAvan's intention is to focus more on patient safety and less on the formation of committees, as she says is the current obsession.

According to O'Donnell's article, in January 2010, the clinical research workshops will look at risk-based approaches and ethics committees. February will be the turn of pharmacovigilance. There will be final conference in April 2010, during which a proposal to the EU will be decided on the way forward for international clinical research trials in Europe.

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Press Release Submitted On: November 20, 2009 at 12:31 am
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