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 Updated on: Jan 9 2014

Clinical network

 

Subject

At present there are several well-functioning national clinical trial groups in Europe, in particular in France, UK, Spain, Netherlands, Germany, Italy and the Nordic countries. Smaller scale groups are present in Austria, Greece, Poland and Turkey.

 

Present Status

A very important development is the rising interest in new member countries to participate in clinical trials, and some of these countries have expressed interest in participation in active trial groups. While there is a common and growing awareness that large cooperative groups are the only means to organize clinical trials on such scale that relevant clinical questions can be addressed, political and emotional arguments have prevented this so far.


Still, few trial groups have managed to organize and complete large phase III trials, including the French IMF group (coordinators: M. Attal, JL Harousseau, T Facon), the Dutch HOVON group (P. Sonneveld, HM Lokhorst), the South-German group (H. Goldschmidt), the Spanish group (J. San Miguel), and the UK Myeloma Forum (JA Child, D Samson).


Preview of Programme Proposed

The goal of the EUMMNE Clinical Network is to bring the presently existing national groups together in order to coordinate clinical research programs and to amplify the potential of the clinical trial programs. Two major reasons for the slow progress of clinical treatment results in myeloma is a) the difficulty to decide on certain treatment options such as high-dose therapy and b) the lack of new effective drugs or treatment options. It should be realised that in order to answer a clinical question in a phase III trial, at least 550 evaluable patients are required to detect a 15 % difference of treatment outcome.

 

National trial groups often need 3-6 years to accomplish such a trial, which forces these groups to continue with ongoing trials even when new relevant questions have become more prominent. In addition there is a significant overlap and redundancy in trial design and outcome variables between these national trials, as has been recently demonstrated with Thalidomide.

 

Establishing a European Network for clinical trials could overcome this restriction. It is the goal of this workpackage to bring the national groups together to create a common trial forum. All above-mentioned clinical trial groups have expressed their commitment to such an enterprise. Concrete goals of the Clinical Network will be:

  1. to identify and describe the structure, organisation and background of each national or regional clinical trial group for multiple myeloma;  
     
  2. to make an overview of current, ongoing clinical trials and plans for future trials in myeloma in the different trial groups;

  3. to make the information on these trials accessible through the EUMMNE Home Page, and to publish the criteria for active participation by new member states and other centres;

  4. to create a structure for participation by the active trial groups in one or more large scale trials, for example trials that require large numbers of patients or trials in subcategories of patients that are less commonly available. The concrete aim of this part will be realised by exploring the following realistic options:

    • to define a common control arm for phase III studies that are performed by each group, thus reducing the required number of patients; 

    • to enforce an active cooperation between the statistical units of each trial group, in order to design state of the art trial concepts; 

    • to design cooperative trials for orphan treatments in myeloma, such as allogeneic transplantation, vaccination therapy and gene therapy; 

    • to create cooperation between trial groups who commit themselves to specific clinical aims and are willing to further define a clinical task force to conclude specific goals such as phase I trials, phase II trials, orphan treatment trials or introduction of new methodology

     
  5. finally, there will be an increasing need for epidemiological data concerning treatment and follow up of myeloma patients. It will be a major goal of the EUMMNE network to create a large demographic database from the trial databases that are now available in each trial group. This will require several years to build. However, it is expected that this effort will contribute significantly to epidemiological studies concerning the etiology and long-term follow-up of multiple myeloma.

Deliverables and Cooperations

  • a Clinical Network
  • clinical accrual of at least 1.000 patients in one year, representing a 
    format, never before seen in hematological oncology
  • high quality of data collection and protocol consistency from centers 
    used to participating in large multicenter trials.


It is expected that in the first 18 months the above-mentioned goals 1 through 3 can be realised. An effort will be made to initiate goal 4 during this period, with the aim of starting the first new common all-European myeloma protocol in 2005.

Secr. Hans E. Johnsen | Depart. of Haematology | Aalborg University Hospital | Sdr. Skovvej 15 | DK-9000 Aalborg | Denmark | T:+45 9766 3871 | F:+45 9766 6369