Improving the quality of cancer clinical trials workshop summary (National Academies Press, 2008)
Includes bibliographical references
Introduction -- New clinical trial designs. Phase 0 trials -- Adaptive trial designs -- Targeting multiple pathways with multiple drugs -- Preclinical model systems -- Molecular imaging. Current and developing methods -- Challenges of molecular imaging -- Screening for predictive markers. The challenges of clinical validation -- Bioimaging predictive markers -- Clinical translation -- Panel discussion -- Costs of clinical trials. Regulatory costs -- Patient accrual -- Global outsourcing -- Time is money -- Public-private collaborations -- Regulatory issues. Regulatory barriers to innovation -- Patient advocacy perspective -- Regulation of in vitro diagnostics -- Regulatory issues in improving cancer clinical trials -- Reports from the case study discussion groups. Adaptive trial design -- Phase 0 trials -- Imaging -- Use of proteomics/genomics to assign therapy in lung cancer -- Use of genetics/genomics to assign therapy
Scientists and clinicians seek a new paradigm that could improve the efficiency, cost-effectiveness, and overall success rate of cancer clinical trials, while maintaining the highest standards of quality. To explore innovative paradigms for cancer clinical trials and other ways to improve their quality, the National Cancer Policy Forum held a workshop, Improving the Quality of Cancer Clinical Trials, in Washington, DC. The main goals of the workshop were to examine new approaches to clinical trial design and execution that would: better inform decisions and plans of those responsible for developing new cancer therapies; more rapidly move new diagnostic tests and treatments toward regulatory approval and use in the clinic; and, be less costly than current trials. The resulting workshop summary will serve as input to the deliberations of an Institute of Medicine committee that will develop consensus-based recommendations for moving the field of cancer clinical trials forward