National Cancer Institute
National Cancer Institute U.S. National Institutes of Health

Coordination Initiatives

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