The European Medical Research Councils, the umbrella organisation for medical research foundations based at the European Science Foundation in Strasbourg, is launching an in-depth review of how best to implement investigator-driven clinical trials in Europe to the benefit of patients.
Over the coming year, an expert group under the chairmanship of Professor Jürgen Schölmerich, vice-president of the German Research Foundation (Deutsche Forschungsgemeinschaft), will look at the situation in Europe from an international perspective and make recommendations on the conditions needed to run investigator-driven trials as effectively as possible and facilitate co-operation with non-European countries such as the US.
While pan-European collaboration is an important factor in many clinical trials, it is essential for studies evaluating treatments for rare diseases, which are more likely to be initiated by investigators, the EMRC pointed out. The organisation is co-ordinating two such studies under its Pan-European Clinical Trials programme, part of the wider EUROCORES scheme aimed at promoting collaborative research in Europe.
The EURAMOS trial, which involves 11 European countries as well as the US and Canada, will recruit some 1,400 patients over the next few years to assess whether treatment can be improved for osteosarcoma, the most common bone cancer in children.
People with osteosarcoma are usually first given chemotherapy, then the tumour is surgically removed and another course of chemotherapy follows. The effect of the initial course of chemotherapy can vary however, with poor responders tending to have a worse chance of surviving the disease the EMRC notes. The EURAMOS trial will evaluate a different treatment regime for these poor responders to see if survival rates can be improved.
“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,” noted Professor Stefan Bielack of the Olgahospital in Stuttgart, Germany, who is co-ordinating the EURAMOS trial. “Treatment is complex and collaboration between many centres and different countries is crucial.”
The second trial, PROFIDYS, is looking at the safety, efficacy and tolerability of bisphosphonate drugs in reducing bone pain and osteolytic lesions in patients with fibrous dysplasia of the bone, a rare congenital bone disease characterised by the replacement of normal bone by fibrous-like, disorganised and fragile tissue. Five European countries are taking part in this initiative. The co-ordination centre and national sponsor for PROFIDYS is France’s Institut National de la Santé et de la Recherche Médicale (Inserm).
Because the disease is so rare, said trial co-ordinator Professor Philippe Orcel of the Hôpital Lariboisière in Paris, it is difficult to attract the interest of large pharmaceutical companies. Moreover, a multinational effort is needed to recruit sufficient numbers of patients. “For our trial we wish to include 156 patients,” Professor Orcel commented. “While this might not sound very many, it would be almost impossible to achieve this recruitment in a single European country.”
The EMRC will draw on its experience from these two trials in its review of conditions for investigator-driven studies in Europe.