Agenda and Presentations: Multi-site Clinical Trials and NCI Cooperative Groups
DAY 1: Tuesday, July 1, 2008
7:30am BREAKFAST
8:00 am Welcome and Opening remarks
John Niederhuber, M.D., National Cancer Institute
8:30 am 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.
8:30 am Jeffrey S. Abrams, M.D., National Cancer Institute
“NCI’s Clinical Trials Program”
9:00 am Jan C. Buckner, M.D., Mayo Clinic
“Mayo Clinic and North Central Cancer Treatment Group: An Academic-Community Partnership”
9:30 am Walter J. Curran, Jr., M.D., Winship Cancer Institute, Emory University
“Organization of the Radiation Therapy Oncology Group”
10:00 am David M. Dilts, Ph.D., M.B.A., Vanderbilt University
“Activating & Opening Oncology Clinical Trials: Process & Timing Analysis”
10:30 am Richard L. Schilsky, M.D., University of Chicago, Cancer and Leukemia Group B
“Rising to the Challenge of Rapid Protocol Activation”
11:00 am BREAK
11:15 am SESSION 1B: OPERATION OF PHASE 3 CLINICAL TRIALS
Moderator: Richard L. Schilsky, M.D., University of Chicago
11:15 am Robert M. Califf, M.D., Duke University
“Organization of Multi-center Trials: Are Oncopolitics Different than Other Clinical Research Politics”
11:45 am Renzo Canetta, M.D., Bristol-Myers Squibb
“Industry Sponsored Multi-center Trials”
12:15 am 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”
12:45 pm LUNCH
1:30 pm Session 2: Patient Recruitment and Physician Participation
SESSION 2A: PANEL ON ACADEMIC CHALLENGES
Moderator: John Mendelsohn, M.D., MD Anderson Cancer Center
1:30 pm 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”
1:40 pm Gordon R. Bernard, M.D., Vanderbilt University
“Cancer Clinical Research: The Institutional Perspective”
1:50 pm Michael A. Caligiuri, M.D., The Ohio State University Comprehensive Cancer Center – James Cancer Hospital
2:00 pm Allen S. Lichter, M.D., American Society of Clinical Oncology
“The Pitfalls of Career Advancement for the Clinical Trialists: a Decanal Perspective”
2:10 pm PANEL DISCUSSION
3:00 pm BREAK
3:15 pm SESSION 2B: OTHER PERSPECTIVES
Moderator: Hal Moses, Vanderbilt University
3:15 pm Stephen S. Grubbs, M.D., Delaware Christiana Care CCOP
“CCOP Clinical Trials Contributions and Challenges”
3:45 pm John E. Feldmann, M.D., F.A.C.P., Moses Cone Regional Cancer Center
“Community Cancer Centers - The Crisis in Clinical Trials”
4:15 pm Richard Kaplan, M.D., National Cancer Research Network, United Kingdom
“Publicly-funded Cooperative Groups Working With Industry”
4:45 pm Deborah E. Collyar, Patient Advocates in Research
“Connecting Clinical Trials to People”
5:15 pm Adjourn Day 1
Day 2: Wednesday, July 2, 2008
7:30 am BREAKFAST
8:00 am Welcome and Opening remarks
John Mendelsohn, M.D., MD Anderson Cancer Center
8:15 am Session 3: Data collection standards to establish safety and efficacy
Moderator: Renzo Canetta, M.D., Bristol-Myers Squibb
8:15 am James H. Doroshow, M.D., F.A.C.P., National Institutes of Health
“NIH Perspective”
8:35 am Gwendolyn Fyfe, M.D., Genentech
“A Perspective on How to Quickly Define Data Standards”
8:55 am Robert L. Comis, M.D., Coalition of National Cancer Cooperative Groups
“The Role of Cooperative Groups in Establishing Safety and Efficacy”
9:15 am PANEL DISCUSSION: James Doroshow, Gwendolyn Fyfe, Robert Comis, and Richard Pazdur, M.D., F.A.C.P., FDA
10:00 am BREAK
10:15 am Session 4: Costs/Payments
Moderator: Robert L. Comis, M.D., Coalition of National Cancer Cooperative Groups
10:15 am Al B. Benson, III, M.D., F.A.C.P., Robert H. Lurie Comprehensive Cancer Center
“Cooperative Groups and Cost Analysis”
10:45 am Marcy Waldinger, M.H.S.A., University of Michigan Comprehensive Cancer Center
“Cost-out”
11:15 am
Maurie Markman, M.D., MD Anderson Cancer Center
“Regulatory Compliance: Impact on Patients and Academic Institutions Conducting Clinical Research”
11:45 am Leslye K. Fitterman, Ph.D., Centers for Medicare and Medicaid Services
“CMS Clinical Trial Policy”
12:15 pm Lee N. Newcomer, M.D., M.H.A., United HealthCare
“An Insurer’s View: Paying for Clinical Trials”
12:45 pm Wrap up
John Mendelsohn and Hal Moses
1:00 pm LUNCH and Adjourn Day 2
Back to Meeting