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Paving the way for future pan-European clinical trials
Date:10/9/2007

esigned to assess the safety, tolerability and efficacy of a class of drug called bisphosphonates in the reduction of bone pain and osteolytic lesions in patients with fibrous dysplasia of the bone, a rare congenital bone disease characterized by replacement of normal bone by fibrous-like, disorganised and fragile tissue. Five countries across Europe are involved. The coordination center of the trial is the Institut National de la Sant et de la Recherche Mdicale (Inserm), which acts also as the national sponsor.

Because this is a rare disease it does not get the interest of the big pharmaceutical companies, said Professor Philippe Orcel (Hpital Lariboisire, Paris, France), the trials coordinator. This is one of the very important aspects of this kind of trial. Also because it is so rare we need a multinational effort to recruit enough patients to be able to properly evaluate treatments. For our trial we wish to include 156 patients. While this might not sound very many, it would be almost impossible to achieve this recruitment in a single European country.

Professor Orcel believes that the EMRC is well-placed to coordinate such trials across many countries. Overall we need good coordination and more efficient evaluation and assessment of proposals. It would be better if this was done centrally rather than in each individual country.

Dr Carole Moquin-Pattey, head of the EMRC unit, said, The EMRC now wishes to build on these experiences to develop with the various interested parties an in-depth analysis of the current situation in Europe in an international perspective and make recommendations to allow investigator driven clinical trials to be launched as efficiently as possible for the benefit of European patients. Over the coming year, a high-level experts group under the chairmanship of Professor Jrgen Schlmerich, Regensburg, Vice-president of the Deutsche Forschungsgemeinschaft, will produce recommendations on which are the conditions be
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Contact: Sofia Valleley
svalleley@esf.org
33-388-762-149
European Science Foundation
Source:Eurekalert

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