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.