Improving the Quality of Cancer Clinical Trials: Workshop Summary
2008

Workshop

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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.

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136 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-11668-6
ISBN Ebook: 0-309-11669-4
DOI: https://doi.org/10.17226/12146

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Institute of Medicine. 2008. Improving the Quality of Cancer Clinical Trials: Workshop Summary. Washington, DC: The National Academies Press.

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Front Matter i-xii
Introduction 1-2
New Clinical Trial Designs 3-39
Molecular Imaging 40-48
Screening for Predictive Markers 49-66
Costs of Clinical Trials 67-76
Regulatory Issues 77-88
Reports from the Case Study Discussion Groups 89-100
Concluding Remarks 101-101
References 102-106
Acronyms 107-108
Glossary 109-114
Appendix A: Workshop Agenda 115-122
Appendix B: Workshop Speakers, Moderators, and Invited Discussants 123-124

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Improving the Quality of Cancer Clinical Trials: Workshop Summary (2008)

Chapter: Regulatory Issues

Publication information

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Improving the Quality of Cancer Clinical Trials: Workshop Summary (2008)

Chapter: Regulatory Issues