EORTC Scientific Strategy 2005 - 2010


Overall strategy:

The EORTC is an academic organization whose main objective is to conduct large scale clinical trials aiming at improving the standards of care for cancer patients. Although developing new and innovative therapies is critical for improving cancer care, the primary interest of the organization remains with clinical trials looking at strategic therapeutic questions which will influence medical practice or will improve fundamentally the understanding of the disease.
The EORTC has built an important part of its success on the multidisciplinary approach of cancer treatment and this should remain the principal strength of the EORTC. However, the multidisciplinary approach to research on cancer treatment nowadays also encompasses pathologists and laboratory scientists involved in translational research programmes integrated into the clinical trials. Hence translational research represents an essential component of the EORTC Scientific Strategy also contributing to distinguish simple trials from high quality academically driven studies.
As part of the overall strategy of the EORTC, a Network of Core Institutions (NOCI) is being set up.
The network will be based on core recruiting academic centers across Europe, specifically apt to develop projects with important translational research components. In March 2006, a meeting of interested centres was held. Several projects have been selected to pilot the NOCI structure.

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 is used by the Protocol Review Committee (PRC) to determine the place of each new trial proposal within the overall strategy of the EORTC and allow the Board to assign priorities when there is a competitive process for resources and / or funding. The Scientific Audit Committee (SAC) will take into account this classification when reviewing the overall performance of each Group as well. Category 1.A represents the highest priority and category 3.C the lowest priority. High ranking of a trial does not guarantee financial support by the EORTC.

Category 1

A. Randomized phase III trials aiming at answering a question which directly contributes to define new standards of care (a.o. trials with a strong multidisciplinary component prepared and run jointly by different EORTC groups).

B. 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

A. 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 trials with a clinically relevant question and a translational research component.

B. Phase Ib trials involving drugs with a 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

A. Randomized phase III trials that do not meet the requirements of the above mentioned categories.

B. 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 for later development within the EORTC is lacking.

C. Other phase I and single arm phase II studies.

Notes:
• 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 2.B + …) is assigned 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 are asked to assign a category (as defined above) for each new outline submitted to the PRC. The PRC confirms the category proposed by the group or proposes to change it.

II. Prevention, epidemiology, diagnostic and imaging research

Opportunities for research in these areas which would represent a real added value for the EORTC are 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.