Symptom and Toxicity Drug Development Task Force (DDTF)

The DDTF was formed by the NCI Symptom Management and Quality of Life Steering Committee (SxQOL SC) in response to a lack of agents for amelioration of cancer treatment-related toxicity and cancer-related symptoms. Its purpose is to increase the availability of biologically plausible, pharmacologic interventions for clinical trial assessment that have the potential to reduce cancer treatment-related toxicity or cancer disease-related symptoms.

Benefits:

• Expertise of NCI and its extramural grantees in symptom/toxicity management and in the conduct of early/late phase clinical trial
• Expertise of peer-reviewed, NCI funded clinical trial systems

DDTF members:

• pharmacists, symptom management researchers, medical oncologists, pain researchers, NCI intramural researchers, patient advocates
• ad hoc and new members to be added as needed

General process:

• Potential drugs may be identified for presentation to the DDTF by pharmaceutical companies
• The agents must be suitable for human use n clinical trials, from early phase to late phase studies
• Through an agent review process, DDTF will review the agent and develop recommendations, reporting back to the SxQOL SC

Agent evaluation:

• Contact NCI DDTF co-chair and agent Program Director Joanna M Brell, MD brelljm@mail.nih.gov or (301) 496-8145 for a preliminary discussion regarding suitability of the proposed agent for the DDTF program or if any questions
• If suitable, agent owner will present plans for agent via teleconference to DDTF after confidentiality agreements have been signed by all parties involved
• The DDTTF may obtain ad hoc reviewers as needed to review the agent; a team from the DDTF will lead the DDTF's internal review and may ask for further information from the agent owner. The DDTF, via the SxQOL SC, may recommend or not recommend that the agent be co-developed with NCI

Co-development with NCI:

• Agents that require intensive monitoring for toxicity and dosing will be co-developed with the Cancer Therapy Evaluation Program through their Early Drug Development Program for phase I and Phase II type studies
• Agents with known dosing and safety parameters that are being assessed primarily for their efficacy will be co-developed with DCP through their Community Clinical Oncology Program grantees for Phase II and Phase III type trials
• Both of these NCI divisions are experienced in industry clinical development agreements, including IP issues, which will be mutually agreed upon by agent owner and NCI.
• NCI grantees would develop and write concepts/letters of intent for clinical trials, serving as the principal investigators for the subsequent trials utilizing the agents, with input from agent owner and NCI staff
• After going through the protocol review process, the clinical trials would be conducted through the appropriate NCI clinical trials network

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