Improving the quality of cancer clinical trials : workshop summary / / National Cancer Policy Forum, Margie Patlack and Sharyl Nass, rapporteurs.

• Author: National Cancer Policy Forum (U.S.)
• TeilnehmendeR: Patlak, Margie.; Nass, Sharyl J.; National Cancer Policy Forum (U.S.); Institute of Medicine (U.S.); ProQuest (Firm)
• Year of Publication: 2008
• Language: English
• Physical Description: xii, 124 p. :; ill. (some col.).

Table of Contents

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.