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Agenda and Presentations: Multi-site Clinical Trials and NCI Cooperative Groups Print   Email


 
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

 


Resources And Links
Abrams Presentation
Baker Presentation
Benson Presentation
Bernard Presentation
Buckner Presentation
Califf Presentation
Caligiuri Presentation
Canetta Presentation
Canetta - Session 3 Introduction
Collyar Presentation
Comis Presentation
Curran Presentation
Dilts Presentation
Doroshow Presentation
Feldmann Presentation
Fitterman Presentation
Fyfe Presentation
Grubbs Presentation
Kaplan Presentation
Keller Presentation
Lichter Presentation
Markman Presentation
Newcomer Presentation
Niederhuber Presentation
Schilsky Presentation
Waldinger Presentation


Last Updated: 7/07/2008, 08:34 AM RSS





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