Implementation of the EORTC Scientific Strategy

I. Clinical trials

EORTC Clinical trials can be classified in 3 categories (each including 2 or 3 sub-categories) on the basis of their principal characteristics. This classification will be used by the Protocol Review Committee to determine the place of each new trial proposal into the global strategy of EORTC and by the board to assign priorities when there is a competitive process for resources and / or funding. The Scientific Audit committee will also take into account this classification when reviewing the global performance of each group. Category 1A is the highest priority and category 3C the lowest priority. High ranking for trials does not guarantee financial support by EORTC.

Category 1

1. Randomized phase III trials aiming at answering a question which directly contribute to define new standards of care (a.o. trials with a strong multidisciplinary component prepared and run jointly by different EORTC groups).
2. Randomized phase III trials with a crucially important translational research component that may permit a fundamental advance in the understanding of a particular disease.

Category 2

1. Intergroup randomized phase III trials not lead by an EORTC group but corresponding to the criteria listed under category 1.
   Phase II randomized trials clearly designed as a preparatory work for a following randomized phase III.
   Registration trial with a clinically relevant question and a translational research component.
2. Phase Ib trials involving drugs with novel mechanism of action and with commitment from the company for vertical drug development in the EORTC (including combination studies with radiotherapy and biological agents).

Category 3

1. Randomized phase III trials that do not meet the requirements of the above mentioned categories.
2. Randomized phase II trials with no or a weak translational research component.
   Phase I and single arm phase II trials with drug having truly new mechanisms of action, but for which a plan of later development within the EORTC is lacking.
3. Other phase I and single arm phase II studies.

Implementation

• All clinical trial groups should aim at having at least one trial in category 1 prior to considering trials in other categories.
• A “+” (eg category IIb+…) should be added to trials that also comprise a project aiming at:
  • storing tissue for future research
  • investigating new methodological aspects of clinical research (surrogate endpoints, new designs…)
• Groups will be asked to assign a category (as defined above) for each new outline submitted to the PRC. PRC will confirm the category proposed by the group.

II. Prevention, epidemiology, diagnostic and imaging research

Opportunities for research in these areas which would represent a real added value for the EORTC should be considered on a case by case basis.

III. Tissue banking

• Tissue banking is considered to be an important issue by all the groups and the EORTC should give it a high priority.
• Centralized storage of tissue at the Data Center is not considered a viable option for most of the groups. All efforts from EORTC should therefore be focused on the development of the Virtual Tissue Bank . Centralized tissue storage at the Data Centre or elsewhere should be organized only for specific projects proposed by the groups.