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EORTC AISBL / IVZW |
3. “NOCI” (Network of Core Institutions): moving from a “concept” to a truly efficient network conducting high quality tailored treatment investigations.
4. Enforcing the prioritization of EORTC trials with an increasing proportion of high quality trials with an explanatory component.
Category 1
A. Randomized phase III trials aiming at answering a question which directly contribute to define new standards of care (and amongst others trials with a strong multidisciplinary component, including trials prepared and run jointly by different EORTC groups). B. Randomized phase III trials with a strong targeted translational research component that may permit a fundamental advance in the understanding of a particular disease. C. Intergroup randomized phase III trials not led by an EORTC group but corresponding to the criteria listed under category 1A or 1B. Category 2
A. - 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. B. 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
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 of later development within the EORTC is lacking.C. 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.
- NOCI (+ EORTC lab division) - Disease/treatment oriented groups
5. Maintain and strengthen the EORTC position as leading organization conducting trials in “niche” indications with bio-banking.
6. Take action to meet the financial requirements to realize the scientific agenda in order to establish more effective treatments and change practice.