Prioritization/Scientific Quality Initiatives
Enhanced scientific quality and prioritization of clinical trials is potentially the most important goal for the redesigned NCI clinical trials enterprise. The need for efficient use of resources and the urgency of making new therapies available to patients requires that NCI sponsor the best-designed trials that address the most important questions while leveraging the most significant scientific advances.
Achieving this goal requires that design and prioritization of clinical trials be improved and that the tools of molecular medicine and other correlates of clinical response be applied in a timely, prioritized, and high-quality manner to enhance clinical trial outcomes.
To achieve the goals of more efficient clinical trial design and prioritization, including integration of correlative science and quality-of-life (or outcome) studies, the CTWG proposed the following six new initiatives.
For full details on the initiatives, see the CTWG Report (PDF - 366KB).
The CTWG Prioritization/Scientific Quality Initiatives
Initiative 1: Establish an Investigational Drug Steering Committee to collaborate with NCI in the design and prioritization of early phase drug development trials with agents for which CTEP holds an IND.
Initiative 2: Establish a network of Steering Committees to address the design and prioritization of phase III trials that leverages current Intergroup, Cooperative Group, SPORE, and Cancer Center structures and involves the broad oncology community.
Initiative 3: Enhance patient advocate and community oncologist involvement in clinical trial design and prioritization through representation on Steering Committees and creation of patient advocate and community oncologist focus groups.
Initiative 4: Establish a funding mechanism and prioritization process to ensure that the most important correlative science and quality-of-life studies can be initiated in a timely manner in association with clinical trials.
Initiative 5: Establish a process for ensuring that correlative science studies conducted in association with clinical trials are performed according to standard protocols and standardized laboratory practices.
Initiative 6: Develop a plan for integrating prioritization of all phase II trials performed by Cooperative Groups, SPOREs, Cancer Centers, and P01, R01, and NCI intramural investigators into the processes established by the Investigational Drug Steering Committee and the other CTWG Steering Committees.
The CTWG Prioritization/Scientific Quality Initiatives are implemented by the CTWG Steering Committees.
Biomarker, Imaging, and Quality of Life Studies Funding Program (BIQSFP) is available to funded Cooperative Groups (CGs) and Community Clinical Oncology Program (CCOP) Research Bases to support essential biomarker, imaging, and quality of life studies associated with clinical trial concepts for large (at least 100 patients), randomized phase 2 therapeutic trials and phase 3 therapeutic, cancer prevention, and primary symptom management clinical trials. To date, 14 studies have been funded as part of the BIQSFP program.