Improving the Quality of Cancer Clinical Trials

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: (1) better inform decisions and plans of those responsible for developing new cancer therapies (2) more rapidly move new diagnostic tests and treatments toward regulatory approval and use in the clinic (3) 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. Table of Contents

• Front Matter
• Introduction
• New Clinical Trial Designs
• Molecular Imaging
• Screening for Predictive Markers
• Costs of Clinical Trials
• Regulatory Issues
• Reports from the Case Study Discussion Groups
• Concluding Remarks
• References
• Acronyms
• Glossary
• Appendix A: Workshop Agenda
• Appendix B: Workshop Speakers, Moderators, and Invited Discussants