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Appendix A Workshop Agenda National Cancer Policy Forum Workshop on Multi-Center Phase III Clinical Trials and NCI Cooperative Groups The Keck Center of The National Academies Room 100 500 Fifth Street, NW Washington, DC 20001 Agenda July 1â2, 2008 Day 1: July 1, 2008 Welcome and Opening Remarks 8:00 am â 8:30 am John Niederhuber, NCI Session 1: Organization of the nci clinical trials system and operation of Phase iii clinical trials 8:30 am â 12:45 pm Ã¿ Session 1A: Organization of the nci clinical trial system trials system 8:30 am â 11:00 am Moderator: David Parkinson, Nodality, Inc. Jeffrey S. Abrams, NCI âNCIâs Clinical Trials Programâ 111
112 MULTI-CENTER PHASE III CLINICAL TRIALS Jan C. Buckner, Mayo Clinic âMayo Clinic and North Central Cancer Treatment Group: An Academic-Community Partnershipâ Walter J. Curran, Jr., Winship Cancer Institute, Emory University âOrganization of the Radiation Therapy Oncology Groupâ David M. Dilts, Vanderbilt University âActivating & Opening Oncology Clinical Trials: Process & Timing Analysisâ Richard L. Schilsky, University of Chicago, Cancer & Leukemia Group B âRising to the Challenge of Rapid Protocol Activationâ Break 11:00 am â 11:15 am Ã¿ Session 1B: operation of phase III clinical trials 11:15 am â 12:45 pm Moderator: Richard L. Schilsky, University of Chicago Robert M. Califf, Duke University âOrganization of Multi-Center Trials: Are Oncopolitics Different than Other Clinical Research Politicsâ Renzo Canetta, BristolâMyers Squibb âIndustry-Sponsored Multi-Center Trialsâ Alan Keller, Cancer Care Associates âMulti-Center Clinical Trials in the Community: Models and Methods: What Works, What Doesnât, and Whyâ Lunch Break 12:45 pm â 1:30 pm Session 2: Patient recruitment and physician participation 1:30 pm â 5:15 pm Ã¿ Session 2A: panel on academic challenges 1:30 pm â 3:00 pm Moderator: John Mendelsohn, M. D. Anderson Cancer Center
APPENDIX A 113 Academic Panel: Laurence H. Baker, Southwest Oncology Group and The University of Michigan âSouthwest Oncology Group View of Barriers to Cooperative Group Accrualâ Gordon R. Bernard, Vanderbilt University âCancer Clinical Research: The Institutional Perspectiveâ Michael A. Caligiuri, The Ohio State University Comprehensive Cancer Center â James Cancer Hospital âAccess to Clinical Trials: Impeding the Insuredâ Allen S. Lichter, American Society of Clinical Oncology âThe Pitfalls of Career Advancement for the Clinical Trialists: A Decanal Perspectiveâ Panel Discussion Break 3:00 pm â 3:15 pm Ã¿ Session 2B: other perspectives 3:15 pm â 5:15 pm Moderator: Hal Moses, Vanderbilt University Stephen S. Grubbs, Delaware Christiana Care CCOP âCCOP Clinical Trials Contributions and Challengesâ John E. Feldmann, Moses Cone Regional Cancer Center âCommunity Cancer Centers: The Crisis in Clinical Trialsâ Richard Kaplan, National Cancer Research Network, United Kingdom âPublicly Funded Cooperative Groups Working with Industryâ Deborah Collyar, Patient Advocates in Research âConnecting Clinical Trials to Peopleâ Adjourn Day 1 5:15 pm
114 MULTI-CENTER PHASE III CLINICAL TRIALS Day 2: July 2, 2008 Welcome and Opening Remarks 8:00 am â 8:15 am John Mendelsohn, M. D. Anderson Cancer Center Session 3: Data collection standards to establish safety and efficacy 8:15 am â 10:00 am Moderator: Renzo Canetta, BristolâMyers Squibb James H. Doroshow, National Institutes of Health âNIH Perspectiveâ Gwendolyn Fyfe, Genentech âA Perspective on How to Quickly Define Data Standardsâ Robert L. Comis, Coalition of National Cancer Cooperative Groups âThe Role of Cooperative Groups in Establishing Safety and Efficacyâ Panel Discussion: James Doroshow, Gwendolyn Fyfe, Robert Comis, and Richard Pazdur, FDA Break 10:00 am â 10:15 am Session 4: Costs/Payments 10:15 am â 12:45 pm Moderator: Robert L. Comis, Coalition of National Cancer Cooperative Groups Al B. Benson III, Robert H. Lurie Comprehensive Cancer Center âCooperative Groups and Cost Analysisâ Marcy Waldinger, University of Michigan Comprehensive Cancer Center âCost-outâ Maurie Markman, M. D. Anderson Cancer Center âRegulatory Compliance: Impact on Patients and Academic Institutions Conducting Clinical Researchâ
APPENDIX A 115 Leslye K. Fitterman, CMS âCMS Clinical Trial Policyâ Lee N. Newcomer, UnitedHealthcare âAn Insurerâs View: Paying for Clinical Trialsâ Wrap-up 12:45 pm â 1:00 pm John Mendelsohn and Hal Moses Adjourn Day 2 1:00 pm