Although development of new and innovative therapies is critical for improving cancer care, the primary interests of the EORTC remain with clinical trials that investigate strategic therapeutic questions that will influence medical practice or will fundamentally improve the understanding of a disease.
The EORTC has built an important part of its success on the multidisciplinary approach to cancer treatment, and this remains the principal strength of the EORTC. However, the present-day multidisciplinary approach to research into cancers and their treatment in the clinic also encompasses pathologists and laboratory scientists through translational research programmes that must be integrated into clinical trials. Hence translational research is an essential component of the EORTC Scientific Strategy, and it contributes to the distinction between a ‘simple’ trial and high quality academically driven studies.
The EORTC Scientific Strategy is defined by the EORTC Board and encompasses the following types of clinical trials:
For the EORTC Executive Committee to determine the level of importance of each new trial proposal within the global strategy of the EORTC, for the EORTC Board to assign priorities when there is a competitive process for resources and/or funding, and for the EORTC Scientific Audit Committee to review the global performance of each EORTC Group, three main trial categories have been defined within the priorities of the EORTC. With category 1A representing the highest priority for EORTC involvement and category 3C the lowest, these three categories can be summarised as follows:
Randomised phase III trials that are designed to answer a question that directly contributes to defining a new standard of care as well as other trials with a strong multidisciplinary component and including trials prepared and run jointly by different EORTC Groups;
Randomised phase III trials with a strong targeted translational research component that could provide a fundamental advance in the understanding of a particular disease;
Intergroup randomised phase III trials not led by an EORTC Group but corresponding to the criteria listed under categories 1A and 1B.
Randomised phase II trials clearly designed as a preparatory step for a subsequent phase III trial. Registration trials with a clinically relevant question and a translational research component;
Phase I and phase II trials involving drugs with novel mechanisms of action and with commitment from a company for vertical drug development within the EORTC (including combination studies with radiotherapy and biological agents).
Randomised phase III trials that do not meet the requirements of the above categories;
Randomised phase II trials with a weak or no translational research component. Phase I and single-arm phase II trials using drugs with truly new mechanisms of action, but for which a plan for subsequent development within the EORTC is lacking;
Other phase I and single-arm phase II trials.
The EORTC is committed to conducting academic trials not supported by the pharmaceutical industry. However, close collaboration and partnership with the pharmaceutical industry are essential to develop new agents. The EORTC Board has established criteria to guarantee the EORTC independence in such collaborations. These criteria are:
- Database should be strictly in control of academia.
- Access to primary endpoint by the pharmaceutical industry only at maturity.
- Strict control of biological material by academia.
- IDMC should be coordinated by academia.
- Final analysis and publication under control of academia.