The CTWG addressed three key dimensions of coordination:
- enhanced information sharing
- alignment of incentives to facilitate improved collaboration
- coordination of regulatory strategies and procedures with the scientific enterprise
Improvements in these crucial areas are expected to expedite the delivery of important new cancer therapies to patients. To this end, the CTWG proposed five initiatives aimed at improving coordination and cooperation among functionally diverse components of the current system, including industry and federal regulatory agencies.
For full details on the initiatives, see the CTWG Report (PDF - 366KB).
The CTWG Coordination Initiatives
Initiative 1: Establish a comprehensive database containing regularly updated information on all NCI-funded clinical trials.
Initiative 2: Realign NCI funding, academic recognition, and other incentives to promote collaborative team science and clinical trial cooperation.
Initiative 3: Develop guidelines and procedures for joint participation of FDA and NCI in meetings, including those with industry, concerning new agents and diagnostics.
Initiative 4: Increase awareness of the NCI-FDA expedited concept/protocol approval process, including use of the FDA Special Protocol Assessment.
Initiative 5: In collaboration with the Centers for Medicare and Medicaid Services (CMS) and other payers and stakeholders, establish a robust and transparent process for identifying clinical investigations that might have routine and clinical costs supported using traditional reimbursement mechanisms.
Coordination Initiatives—Key Accomplishments
- NCI's Clinical Trials Reporting Program will establish a comprehensive database containing regularly updated information on all NCI funded interventional clinical trials. Grantees will be requested to enter specific information about each clinical trial into the database. NCI will use this information to coordinate research efforts to optimize our nation's investment in cancer research.
- NCI’s Cancer Clinical Investigator Team Leadership Award recognizes 12 outstanding clinical investigators with a two-year award to acknowledge and support leaders in clinical cancer research programs at NCI Designated Cancer Centers. This second cohort of investigators joins a group of 11 other outstanding clinical investigators who received this prestigious award last year. An updated request for applications from NCI Designated Cancer Centers is anticipated in early 2011.
- An opportunity for Cancer Trials Support Unit (CTSU) support for collaborative multi-center phase 2 trials was released in November. Collaboration is an important underpinning of NCI’s efforts to harmonize review guidelines across Cooperative Groups, NCI Designated Cancer Centers, and Specialized Programs of Research Excellence (SPORE). For clinical trial collaborations requiring multi-center coordinating support that is not otherwise available through existing networks, NCI will prioritize requests for in-kind coordination support through its CTSU.