EMRC to review investigator-driven trials across Europe

PRLog (Press Release) – Oct 16, 2007 – The European Medical Research Councils, part of the European Science Foundation (ESF, Strasbourg, France), is to undertake a review of how best to implement clinical trials that are initiated by investigators. Pan-European collaboration is important for many trials and essential for those investigating treatments for rare diseases, where there are insufficient numbers of patients in any single country, says the EMRC. The review will draw upon the experiences of two pan-European trials in rare diseases currently being co-ordinated by the EMRC, the membership organisation for European medical research councils.

The review will be undertaken by a high-level expert group, chaired by Professor Jürgen Schölmerich, Regensburg, vice-president of the Deutsche Forschungsgemeinschaft. The group is expected to issue recommendations, which will also cover co-operation with other countries, such as the US, within the coming year.

The two trials currently underway, under the ESF’s pan-European clinical trials programme, are investigating treatments for the rare bone conditions, osteosarcoma and fibrous dysplasia. They are being co-ordinated through the ESF’s EUROCORES scheme, a framework to promote and stimulate European collaborative research.

The EURAMOS clinical trial, which involves collaboration across 11 European countries, as well as the US and Canada, is recruiting some 1,400 patients over the next few years to study treatments for osteosarcoma, the most common bone cancer in children. It has already recruited more patients than any other osteosarcoma trial. “While sarcomas are rare, accounting for less than 1% of all cancers, they are some of the most frequent that occur in childhood and adolescence. Treatment is complex and collaboration between many centres and different countries is crucial,” said trial co-ordinator Professor Stefan Bielack (Olgahospital, Stuttgart, Germany).

The second trial being undertaken, PROFIDYS, is assessing the safety, tolerability and efficacy of bisphosphonate drugs in the reduction of bone pain and osteolytic lesions in patients with fibrous dysplasia of the bone. This is a rare congenital disease in which normal bone is replaced by fibrous-like, disorganised and fragile tissue. Five countries across Europe are involved in the trial, co-ordinated by the French Institut National de la Santé et de la Recherche Médicale (Inserm).

“Because this is a rare disease it does not get the interest of the big pharmaceutical companies,” said trial co-ordinator Professor Philippe Orcel (Hôpital Lariboisière, Paris, France). “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.” Article submitted by www.jobs4drugdevelopment.com