National Academies Press: OpenBook

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

Chapter: Appendix A: Workshop Agenda

« Previous: Glossary
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Improving the Quality of Cancer Clinical Trials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12146.
×
Page 115
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Improving the Quality of Cancer Clinical Trials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12146.
×
Page 116
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Improving the Quality of Cancer Clinical Trials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12146.
×
Page 117
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Improving the Quality of Cancer Clinical Trials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12146.
×
Page 118
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Improving the Quality of Cancer Clinical Trials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12146.
×
Page 119
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Improving the Quality of Cancer Clinical Trials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12146.
×
Page 120
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Improving the Quality of Cancer Clinical Trials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12146.
×
Page 121
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2008. Improving the Quality of Cancer Clinical Trials: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12146.
×
Page 122

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Appendix A Workshop Agenda National Cancer Policy Forum Workshop on Improving the Quality of Cancer Clinical Trials The Keck Center of  The National Academies Room 100 500 Fifth Street, NW Washington, DC 20001 Agenda October 4–5, 2007 Day 1: October 4, 2007 Welcome and Opening Remarks 8:00 am – 8:15 am John Mendelsohn, M.D., MD Anderson Cancer Center Session 1: New Clinical Trial Designs 8:15 am – 10:45 am A) Exploratory INDs and Phase 0 Trials 8:15 am – 9:45 am Moderator: James Doroshow, M.D., NCI 115

116 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS David Jacobson-Kram, Ph.D., FDA  “Overview of the Exploratory IND: Differences in the Traditional IND” George Mills, M.D., Parexel International Corporation  “Molecular Imaging and Nanotechnology: Strategic Implementation of the 2006 Exploratory IND Guidance” James Doroshow, M.D., NCI  “Phase 0 Clinical Trials in Cancer Drug Development: From Concept to Practice” B) Adaptive Trial Designs 9:45 am – 10:45 am Moderator: John Wagner, M.D., Ph.D., Merck Don Berry, Ph.D., MD Anderson Cancer Center “Adaptive Designs for Cancer Trials” Susan Ellenberg, Ph.D., University of Pennsylvania “Adaptive Designs in Cancer Trials: Consensus and Debate” Break 10:45 am – 11:00 am Session 1 Resumes 11:00 am – 12:30 pm C) Targeting Multiple Pathways with Multiple Drugs 11:00 am – 12:00 pm Moderator: Roy Herbst, M.D., Ph.D., MD Anderson Cancer Center Janet E. Dancey, M.D., NCI  “Strategies to Develop Combinations of Investigational Agents” Joe Gray, Ph.D., UCSF Comprehensive Cancer Center  “Modeling Molecular Heterogeneity to Enhance Multidrug Clinical Trial Design”

APPENDIX A 117 D) Preclinical Model Systems 12:00 pm – 12:30 pm Ken Anderson, M.D., Dana-Farber Cancer Institute  “Translation from Preclinical Model Systems to the Bedside in Multiple Myeloma” Lunch Break 12:30 pm – 1:15 pm Session II: Molecular Imaging 1:15 pm – 3:15 pm Moderators: Hedvig Hricak, M.D., Ph.D., Memorial Sloan- Kettering Cancer Center, and David Piwnica-Worms, M.D., Ph.D., Washington University School of Medicine Introduction and Mission Statement  Hedvig Hricak, M.D., Ph.D., Memorial Sloan-Kettering Cancer Center Lawrence Schwartz, M.D., Memorial Sloan-Kettering Cancer Center “Imaging Studies That Facilitate Clinical Trials Today” Steven Larson, M.D., Memorial Sloan-Kettering Cancer Center “Molecular Imaging: Biomarkers for Oncology” John Gore, Ph.D., Vanderbilt University “Imaging Biomarkers on the Near Horizon” David Piwnica-Worms, M.D., Ph.D., Washington University School of Medicine “Molecular Imaging Strategies in Drug Development” Panel Discussion Tim McCarthy, Ph.D., Pfizer Jeff Evelhoch, Ph.D., Amgen, Inc. Jerry Collins, Ph.D., NCI Break 3:15 pm – 3:30 pm

118 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS Breakout Discussions: Case Studies of Clinical Trial Designs 3:30 pm – 5:30 pm 1) Phase 0 Trials Moderator/Reporter: Giulio Draetta , M.D., Ph.D., Merck James Doroshow, M.D., NCI Invited Discussant: Richard Schilsky, M.D., University of Chicago 2) Adaptive Trial Design Moderator/Reporter: John Wagner, M.D., Ph.D., Merck Lung Cancer Personalized Therapy Jack Lee, Ph.D., MD Anderson Cancer Center  “Design for Targeted Therapies in Lung Cancer: Statistical Considerations” Roy Herbst, M.D., Ph.D., MD Anderson Cancer Center “Toward Personalized Therapy for Lung Cancer” Invited Discussant: Rick Chappell, Ph.D., University of Wisconsin  “Comments on the Controversy Over Response-Adaptive Randomization” 3) Imaging Moderators/Reporters: David Piwnica-Worms, M.D., Ph.D., Washington University School of Medicine, and Hedvig Hricak, M.D., Ph.D., Memorial Sloan-Kettering Cancer Center Tim McCarthy, Ph.D., Pfizer Jeff Evelhoch, Ph.D., Amgen, Inc.  “Incorporating Imaging Biomarkers in Phase I Oncology Trials”

APPENDIX A 119 4)  se of Proteomics/Genomics to Assign Therapy in Lung U Cancer Moderator/Reporter: John Mendelsohn, M.D., MD Anderson Cancer Center Proteomics and Lung Cancer Prediction (EGFR) David Carbone, M.D., Ph.D., Vanderbilt University  “Molecular Signatures to Guide Selection of Lung Cancer Patient Therapy” Use of Genomics to Assign Therapy in Lung Cancer (genetic targets for Iressa and Tarceva)  William Pao, M.D., Ph.D., Memorial Sloan-Kettering Cancer Center  Mark Kris, M.D., Memorial Sloan-Kettering Cancer Center  “The Lung Cancer Oncogenome Group: Bedside to Bench and Beyond” 5) Use of Genetics/Genomics to Assign Therapy Moderator/Reporter: Pierre Massion, M.D., Vanderbilt University Breast Cancer Personalized Therapy: The TailoRx Trial  Joseph Sparano, M.D., Albert Einstein Comprehensive Cancer Center “Rationale for and Design of TAILORx” Steven Shak, M.D., Genomic Health  “The 21 Gene Oncotype DX Assay and the NCI- Sponsored TAILORx” Using Genetic and Genomic Technologies in Design and Execution of Cancer Clinical Trials  Raju Kucherlapati, Ph.D., Harvard Partners Center for Genetics and Genomics Invited Discussant: David Chang, M.D., Ph.D., Amgen, Inc.

120 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS Adjourn Day 1 5:30 pm Day 2: October 5, 2007 Welcome and Opening Remarks 8:00 am – 8:15 am Hal Moses, M.D., Vanderbilt University Session III: Screening for Predictive Markers 8:15 am – 10:15 am Moderator: George Mills, M.D., Parexel International Corporation Pierre Massion, M.D., Vanderbilt University  “Are Genomics and Proteomics Biomarkers Ready for Prime Time?” James Heath, Ph.D., California Institute of Technology  “Lowering the Cost of In Vitro Diagnostics Measurements Associated with Clinical Trials by a Factor of 10 (or more)” Daniel Sullivan, M.D., Duke University “Is There a Role for Imaging as a Predictive Biomarker?” Daniel Von Hoff, M.D., Translational Genomics Research Institute  “Improving a Patient’s Chance of Benefiting from Early Clinical Trials” Break 10:15 am –10:30 am

APPENDIX A 121 Session IV: Collaborations Among Academia, Pharma, Biotech, and Government 10:30 am – 12:30 pm Moderator: John Mendelsohn, M.D., MD Anderson Cancer Center Robert Comis, M.D., Coalition of National Cancer Cooperative Groups “The Public Sector Perspective” Kevin Schulman, M.D., Duke University Medical School “Cost of Clinical Trials” Gwen Fyfe, M.D., Genentech “The Industry Perspective” Lunch Break 12:30 pm – 1:15 pm Session V: Regulatory Issues 1:15 pm – 3:15 pm Moderator: Janet Woodcock, M.D., FDA Susan Jerian, M.D., OncoRD, Inc.  “The Interplay of Laws, Regulations, and Policies: Moving Cancer Therapeutics Development Out of the Quagmire” Ellen Stovall, National Coalition for Cancer Survivorship  “Clinical Trial Design, Drug Development, and Policy Issues of Importance to Cancer Advocates” Janet Woodcock, M.D., FDA “Issues in Cancer Drug Development of the Future” Steven Gutman, M.D., FDA “Regulation of Biomarkers”

122 IMPROVING THE QUALITY OF CANCER CLINICAL TRIALS Reports from the Case Study Discussion Groups 3:15 pm –�������� ��������� 4:15 pm Giulio Draetta, M.D., Ph.D., Merck Research Laboratories “Phase 0 Trials” Roy Herbst, M.D., Ph.D., MD Anderson Cancer Center “Adaptive Trial Design” David Pinwica-Worms, M.D., Ph.D., Washington University School of Medicine, and Hedvig Hricak, M.D., Ph.D., Memorial Sloan-Kettering Cancer Center “Imaging” John Mendelsohn, M.D., MD Anderson Cancer Center “Use of Proteomics/Genomics to Assign Therapy in Lung Cancer” Pierre Massion, M.D., Vanderbilt University “Use of Genetics/Genomics to Assign Therapy”� Wrap-Up/Summary 4:15 pm – 4:30 pm John Mendelsohn, M.D., MD Anderson Cancer Center, and Hal Moses, M.D., Vanderbilt-Ingram Cancer Center Adjourn Day 2 4:30 pm

Next: Appendix B: Workshop Speakers, Moderators, and Invited Discussants »
Improving the Quality of Cancer Clinical Trials: Workshop Summary Get This Book
×
Buy Paperback | $46.00 Buy Ebook | $36.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

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.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  6. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  7. ×

    View our suggested citation for this chapter.

    « Back Next »
  8. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!