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The Changing Face of Clinical Trials in the EU

By Jan Barfoot - Posted on 06 March 2013

Prof Michele de LucaProf Michele de LucaOptiStem collaborated with the European Parliament Office in Lordon to organsie an event last Friday (22nd Feb), looking into the changes being made to the way that clinical trials are to be conducted in Europe.  The event, which took place at Europe House in London, provided interesting insights into some of the many considerations associated with revising the EU Clinical Trials Directive into a regulation. 

Since its introduction in 2001, the EU Clinical Trials Directive has been widely criticised by industry, patients, and researchers for being overly bureaucratic and for hindering the development of new drugs.  Under the Directive, the number of clinical trials conducted in Europe fell by 25% between 2007 and 2011. 

The revision aims to streamline clinical trials regulatory processes, reduce costs, and increase transparency. 

The event opened with statements from a panel of invited speakers, including Glenis Willmott MEP, who was appointed by the European Commission (EC) to oversee the changes being made to the EU Clinical Trials Directive. 

Also on the panel was Stefano Soro, head of unit within the EC’s Directorate-General Health and Consumers, Dr Liz Philpots, head of research at the Association of Medical Research Charities (AMRC), and Professor Michele de Luca, a Principal Investigator of OptiStem. 

PanellistsPanellistsThe panel addressed a range of questions from a diverse audience that included representatives from research councils, the pharmaceutical industry, and the media.  Of particular note was the considerable amount of support, among both panel and audience members, for there being far greater transparency in clinical trials and better access to clinical trials data. 

After the event, OptiStem spoke to a number of attendees, who were impressed by the calibre of the invited panel and by what was covered on the day.  Overall, attitudes to the proposed revision of the EU Clinical Trials Directive appear very positive indeed. 


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