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Agenda and Presentations: Multi-site Clinical Trials and NCI Cooperative Groups
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| DAY 1: |
Tuesday, July 1, 2008 |
| 7:30am |
BREAKFAST |
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8:00 am
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Welcome and Opening remarks
John Niederhuber, M.D., National Cancer Institute
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8:30 am
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Session 1: Organization of the NCI Clinical Trials System and Operation of Phase 3 Clinical Trials
SESSION 1A: ORGANIZATION OF THE NCI CLINICAL TRIALS SYSTEM
Moderator: David Parkinson, M.D., Nodality, Inc.
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8:30 am
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Jeffrey S. Abrams, M.D., National Cancer Institute
“NCI’s Clinical Trials Program”
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9:00 am
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Jan C. Buckner, M.D., Mayo Clinic
“Mayo Clinic and North Central Cancer Treatment Group: An Academic-Community Partnership”
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9:30 am
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Walter J. Curran, Jr., M.D., Winship Cancer Institute, Emory University
“Organization of the Radiation Therapy Oncology Group”
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10:00 am
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David M. Dilts, Ph.D., M.B.A., Vanderbilt University
“Activating & Opening Oncology Clinical Trials: Process & Timing Analysis”
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10:30 am
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Richard L. Schilsky, M.D., University of Chicago, Cancer and Leukemia Group B
“Rising to the Challenge of Rapid Protocol Activation”
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11:00 am
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BREAK
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11:15 am
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SESSION 1B: OPERATION OF PHASE 3 CLINICAL TRIALS
Moderator: Richard L. Schilsky, M.D., University of Chicago
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11:15 am
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Robert M. Califf, M.D., Duke University
“Organization of Multi-center Trials: Are Oncopolitics Different than Other Clinical Research Politics”
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11:45 am
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Renzo Canetta, M.D., Bristol-Myers Squibb
“Industry Sponsored Multi-center Trials”
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12:15 am
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Alan Keller, M.D., F.A.C.P., Cancer Care Associates
“Multi-site Clinical Trials in the Community: Models and Methods: What Works, What Doesn’t, and Why”
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12:45 pm
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LUNCH
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1:30 pm
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Session 2: Patient Recruitment and Physician Participation
SESSION 2A: PANEL ON ACADEMIC CHALLENGES
Moderator: John Mendelsohn, M.D., MD Anderson Cancer Center
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1:30 pm
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Academic Panel:
Laurence H. Baker, D.O., Southwest Oncology Group and The University of Michigan
“Southwest Oncology Group View of Barriers to Cooperative Group Accrual”
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1:40 pm
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Gordon R. Bernard, M.D., Vanderbilt University
“Cancer Clinical Research: The Institutional Perspective”
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1:50 pm
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Michael A. Caligiuri, M.D., The Ohio State University Comprehensive Cancer Center – James Cancer Hospital
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2:00 pm
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Allen S. Lichter, M.D., American Society of Clinical Oncology
“The Pitfalls of Career Advancement for the Clinical Trialists: a Decanal Perspective”
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2:10 pm
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PANEL DISCUSSION
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3:00 pm
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BREAK
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3:15 pm
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SESSION 2B: OTHER PERSPECTIVES
Moderator: Hal Moses, Vanderbilt University
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3:15 pm
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Stephen S. Grubbs, M.D., Delaware Christiana Care CCOP
“CCOP Clinical Trials Contributions and Challenges”
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3:45 pm
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John E. Feldmann, M.D., F.A.C.P., Moses Cone Regional Cancer Center
“Community Cancer Centers - The Crisis in Clinical Trials”
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4:15 pm
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Richard Kaplan, M.D., National Cancer Research Network, United Kingdom
“Publicly-funded Cooperative Groups Working With Industry”
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4:45 pm
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Deborah E. Collyar, Patient Advocates in Research
“Connecting Clinical Trials to People”
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5:15 pm
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Adjourn Day 1
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Day 2:
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Wednesday, July 2, 2008
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7:30 am
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BREAKFAST
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8:00 am
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Welcome and Opening remarks
John Mendelsohn, M.D., MD Anderson Cancer Center
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8:15 am
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Session 3: Data collection standards to establish safety and efficacy
Moderator: Renzo Canetta, M.D., Bristol-Myers Squibb
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8:15 am
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James H. Doroshow, M.D., F.A.C.P., National Institutes of Health
“NIH Perspective”
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8:35 am
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Gwendolyn Fyfe, M.D., Genentech
“A Perspective on How to Quickly Define Data Standards”
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8:55 am
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Robert L. Comis, M.D., Coalition of National Cancer Cooperative Groups
“The Role of Cooperative Groups in Establishing Safety and Efficacy”
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9:15 am
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PANEL DISCUSSION: James Doroshow, Gwendolyn Fyfe, Robert Comis, and Richard Pazdur, M.D., F.A.C.P., FDA
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10:00 am
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BREAK
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10:15 am
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Session 4: Costs/Payments
Moderator: Robert L. Comis, M.D., Coalition of National Cancer Cooperative Groups
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10:15 am
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Al B. Benson, III, M.D., F.A.C.P., Robert H. Lurie Comprehensive Cancer Center
“Cooperative Groups and Cost Analysis”
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10:45 am
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Marcy Waldinger, M.H.S.A., University of Michigan Comprehensive Cancer Center
“Cost-out”
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11:15 am
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Maurie Markman, M.D., MD Anderson Cancer Center
“Regulatory Compliance: Impact on Patients and Academic Institutions Conducting Clinical Research”
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11:45 am
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Leslye K. Fitterman, Ph.D., Centers for Medicare and Medicaid Services
“CMS Clinical Trial Policy”
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12:15 pm
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Lee N. Newcomer, M.D., M.H.A., United HealthCare
“An Insurer’s View: Paying for Clinical Trials”
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12:45 pm
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Wrap up
John Mendelsohn and Hal Moses
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| 1:00 pm |
LUNCH and Adjourn Day 2 |
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Last Updated: 7/07/2008, 08:34 AM
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