Steering Committees

Investigational Drug Steering Committee

The Investigational Drug Steering Committee (IDSC) is comprised of NCI grant and contract Principal Investigators conducting phase 1 and phase 2 clinical trials of new anti-cancer agents, plus additional experts in biostatistics, imaging, radiation oncology, and drug development. Their input into NCI’s drug development process augments the expertise of NCI staff.

Roles and Responsibilities:

• Conduct strategic discussions regarding early phase drug development trials involving agents for which CTEP holds an IND.

• Prior to Letter of Intent (LOI) solicitation, provide input regarding Clinical Development Plans prepared by CTEP staff for all new drugs and selected current drugs. As Clinical Development Plans evolve over time, provide continued input.

• Periodically assess, from a strategic perspective, CTEP-approved LOIs as well as unsolicited LOIs that were rejected to analyze if the Clinical Development Plan for an agent should be modified.

• Address specific scientific and/or clinical questions with regard to early stage clinical trials and particular drugs or drug classes, as requested by CTEP staff or others in the oncology drug development community.
• Serve as liasons to the Disease-Specific Steering Committees to inform them of new drug development.

• Establish strong, integrative communication links with the Drug Development Group (DDG) at NCI.

• Provide input regarding the resolution of investigator appeals of NCI CTEP LOI decisions.

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.