Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary (2009)

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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 1–2, 2008 Day 1: July 1, 2008 Welcome and Opening Remarks 8:00 am – 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 – 12:45 pm ÿ Session 1A: Organization of the nci clinical trial system trials system 8:30 am – 11:00 am Moderator: David Parkinson, Nodality, Inc. Jeffrey S. Abrams, NCI “NCI’s Clinical Trials Program” 111 

112 MULTI-CENTER PHASE III CLINICAL TRIALS Jan C. Buckner, Mayo Clinic  “Mayo Clinic and North Central Cancer Treatment Group: An Academic-Community Partnership” Walter J. Curran, Jr., Winship Cancer Institute, Emory University “Organization of the Radiation Therapy Oncology Group” David M. Dilts, Vanderbilt University  “Activating & Opening Oncology Clinical Trials: Process & Timing Analysis” Richard L. Schilsky, University of Chicago, Cancer & Leukemia Group B “Rising to the Challenge of Rapid Protocol Activation” Break 11:00 am – 11:15 am ÿ Session 1B: operation of phase III clinical trials 11:15 am – 12:45 pm Moderator: Richard L. Schilsky, University of Chicago Robert M. Califf, Duke University “Organization of Multi-Center Trials: Are Oncopolitics Different than Other Clinical Research Politics” Renzo Canetta, Bristol–Myers Squibb “Industry-Sponsored Multi-Center Trials” Alan Keller, Cancer Care Associates “Multi-Center Clinical Trials in the Community: Models and Methods: What Works, What Doesn’t, and Why” Lunch Break 12:45 pm – 1:30 pm Session 2: Patient recruitment and physician participation 1:30 pm – 5:15 pm ÿ Session 2A: panel on academic challenges 1:30 pm – 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  “Southwest Oncology Group View of Barriers to Cooperative Group Accrual” Gordon R. Bernard, Vanderbilt University “Cancer Clinical Research: The Institutional Perspective” Michael A. Caligiuri, The Ohio State University Comprehensive Cancer Center – James Cancer Hospital “Access to Clinical Trials: Impeding the Insured” Allen S. Lichter, American Society of Clinical Oncology  “The Pitfalls of Career Advancement for the Clinical Trialists: A Decanal Perspective” Panel Discussion Break 3:00 pm – 3:15 pm ÿ Session 2B: other perspectives 3:15 pm – 5:15 pm Moderator: Hal Moses, Vanderbilt University Stephen S. Grubbs, Delaware Christiana Care CCOP “CCOP Clinical Trials Contributions and Challenges” John E. Feldmann, Moses Cone Regional Cancer Center “Community Cancer Centers: The Crisis in Clinical Trials” Richard Kaplan, National Cancer Research Network, United Kingdom  “Publicly Funded Cooperative Groups Working with Industry” Deborah Collyar, Patient Advocates in Research “Connecting Clinical Trials to People” 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 – 8:15 am John Mendelsohn, M. D. Anderson Cancer Center Session 3: Data collection standards to establish safety and efficacy 8:15 am – 10:00 am Moderator: Renzo Canetta, Bristol–Myers Squibb James H. Doroshow, National Institutes of Health “NIH Perspective” Gwendolyn Fyfe, Genentech “A Perspective on How to Quickly Define Data Standards” Robert L. Comis, Coalition of National Cancer Cooperative Groups  “The Role of Cooperative Groups in Establishing Safety and Efficacy” Panel Discussion: James Doroshow, Gwendolyn Fyfe, Robert Comis, and Richard Pazdur, FDA Break 10:00 am – 10:15 am Session 4: Costs/Payments 10:15 am – 12:45 pm Moderator: Robert L. Comis, Coalition of National Cancer Cooperative Groups Al B. Benson III, Robert H. Lurie Comprehensive Cancer Center “Cooperative Groups and Cost Analysis” Marcy Waldinger, University of Michigan Comprehensive Cancer Center “Cost-out” Maurie Markman, M. D. Anderson Cancer Center  “Regulatory Compliance: Impact on Patients and Academic Institutions Conducting Clinical Research” 

APPENDIX A 115 Leslye K. Fitterman, CMS “CMS Clinical Trial Policy” Lee N. Newcomer, UnitedHealthcare “An Insurer’s View: Paying for Clinical Trials” Wrap-up 12:45 pm – 1:00 pm John Mendelsohn and Hal Moses Adjourn Day 2 1:00 pm