Restructuring NCI Clinical Trials Prioritization Process – Steering Committees

The Disease-Specific Scientific Steering Committees will leverage existing Intergroup, Cooperative Group, SPORE, and Cancer Center structures for each major disease area as well as for pediatric oncology and symptom management/supportive care to address, design and prioritize phase 3 trials. All phase 3 concepts and protocols and selected phase 2 protocols funded by NCI will eventually be prioritized through this process. This system is designed to promote an open, collaborative process for setting clinical trial priorities and reducing duplication and overlap. The Scientific Steering Committees are designed to provide robust analysis of proposed concepts and facilitate the sharing of ideas among a broad range of clinical investigators, basic and translational scientists, NCI staff, community oncologists, and patient advocates in the development of those concepts.

Roles and Responsibilities:

• Organize periodic State-of-the-Science Meetings to identify critical questions and unmet needs, to prioritize key strategies and future concepts to test, and to facilitate innovation.
• Develop key strategic priorities for future phase 3 trials including both near-term and long-term initiatives and disseminate these priorities to the relevant oncology communities.
• Develop phase 3 concepts from an elemental stage, as well as evaluate and refine ideas for phase 3 trials developed by Cooperative Group Disease Committees or investigators from Cancer Centers, SPOREs, P01s, etc.
• Work to achieve consensus on which concepts should be submitted to NCI for approval.
• Submit concepts to NCI through the lead Cooperative Group for that concept. If the concept originated outside the Cooperative Group structure, the originating investigator will serve as the Principal Investigator (PI) and the Scientific Steering Committee will select a Cooperative Group partner who will appoint a co-PI for the concept.
• Once the concept is approved by NCI, a protocol will be prepared by the lead Cooperative Group jointly with NCI. The Scientific Steering Committee will be given the opportunity to comment on the protocol before NCI provides its approval.