Nowadays, many cancer research groups conduct clinical trials, and within this framework closer collaboration between research groups is essential to minimize the number of competitive trials and to accrue large numbers of patients in a minimum period of time. These collaborative clinical trials are called ‘Intergroup’ trials.
In order to guarantee the quality of these trials and to facilitate their coordination and logistics, the EORTC has developed procedures and templates specific to this type of trials. These documents were made taking into account the legal requirements in Europe but also the policies of major cancer research groups outside Europe (such as NCI policies). Following these policies, all groups within a trial use the same protocol, the same set of CRFs, and a central database which is the first guarantee for consistency of results.
The data from all collaborating groups are centrally managed for consistent update and validation process.
Apart from the centralization of data, the coordinating center ensures the coordination of the trial logistics and legal aspects. This coordinating role is essential within the new legal framework in the EU. The EU lead group shall, among other tasks, ensure that request of EudraCT number, completion of the clinical trial application form and the reporting to the EUDRAVIGILANCE database are taken care of centrally.
Responsibilities are discussed on a trial-by-trial basis and fixed through written agreements between all involved partners. A Steering Committee composed of representatives from all participating groups decides on the scientific content of the trial and possible future use made of the material, data, and results. These policies have been applied by the EORTC for several years and have resulted in an important number of collaborations with many European and overseas cancer clinical research groups.