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

Pan-European collaboration is important for many clinical trials and essential for trials that are investigating treatments for rare diseases. That was the message delivered today by the European Medical Research Councils (EMRC), the membership organisation for medical research councils across Europe based at the European Science Foundation (ESF) in Strasbourg, which is coordinating two trials in rare diseases and about to launch a review of how best to implement clinical trials that are initiated by investigators. This forward look, will draw upon the experiences of the two trials that are underway.

For many rare conditions, there are insufficient numbers of patients in any single country to allow meaningful clinical trials to seek better treatments. To overcome this problem the ESF programme called Pan-European Clinical Trials (ECT) has seen the successful launch of two trials into rare bone conditions, osteosarcoma and fibrous dysplasia. The two trials now underway are being coordinated through the ESFs EUROCORES scheme, which is a framework to promote and stimulate European collaborative research. While setting up these two trials, the coordinators had to overcome a number of challenges.

The EURAMOS clinical trial, which involves collaboration across 11 European countries, as well as the USA and Canada, is recruiting some 1,400 patients over the next few years to improve treatment for osteosarcoma, the most common bone cancer in children. The trial has already recruited more patients than any other osteosarcoma trial ever performed. Professor Stefan Bielack (Olgahospital, Stuttgart, Germany), the coordinator of the EURAMOS trial, said, While sarcomas are rare, accounting for less than one per cent 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.

The second trial being undertaken, PROFIDYS, is designed 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 best adapted to run the investigator driven clinical trials needed for Europe and also to enable closer cooperation with other non-European countries such as the USA.


'/>"/>

Contact: Sofia Valleley
svalleley@esf.org
33-388-762-149
European Science Foundation
Source:Eurekalert

Related medicine news :

1. Low Birth Weight infants could have Problems in the Future
2. Eyes,The Window To The Future
3. Needle free future for diabetics
4. Oral memory indicates future Alzheimers patients
5. New Virus : A Threat In the Future?
6. Will Your Baby Grow Up To Be A Future Einstein ?
7. Genetic Pills A Future Thought
8. Prediction Of Disease In The Future Questioned
9. Asthmatics May Be At Risk for Lung Disease In The Future
10. Use Of Sunscreen In Childhood And Prevents Future Skin Cancer
11. Childrens Waistlines A Predictor Of Future Heart Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... ... 2016 , ... W.S. Badger Co. Inc ., the maker of certified ... Work Works Award for its use of effective workplace strategies to increase business and ... administered by the Families and Work Institute (FWI) and the Society for Human Resource ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... ... and clinical outcomes, hosted members and suppliers for its inaugural Member Conference at ... on their mission of elevating the operational health of America’s healthcare providers. , ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... Connor ... women’s basketball as a partner for the Tamika Catchings Legacy Tour that ... the industry leader in hardwood basketball surfaces in all forms and levels of the ...
(Date:5/26/2016)... ... May 26, 2016 , ... The Woodlands at John ... a new model of care for living and healing, celebrated its grand opening, today. ... in a Real Home provided by Empowered Staff. , “This is an incredibly fulfilling ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... There are ... more than 32 million cancer survivors worldwide. On Sunday, June 5, 2016, communities around ... annual National Cancer Survivors Day®. , National Cancer Survivors Day® is an annual ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... 2016   , Study ... overall bowel cleansing and superiority in , ... of the ascending colon ... Norgine B.V. today announced new positive data from the ... bowel preparation) versus standard 2 litre PEG with ascorbate. The study ...
(Date:5/24/2016)... LAWRENCEVILLE, N.J. , May 24, 2016 /PRNewswire/ ... an oncology drug development company, today provided an ... Ib dose escalating clinical trial combining GEN-1, the ... for the treatment of newly-diagnosed patients with advanced ... by interval debulking surgery.  GEN-1 is an IL-12 ...
(Date:5/24/2016)... KONG , May 24, 2016 /PRNewswire/ ... COMBO ™ , la première ... des cathéters destinés à l,intervention portant sur ... (FAV)   OrbusNeich, entreprise mondiale ... permettant de changer la vie, a élargi ...
Breaking Medicine Technology: