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Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary (2013)

Chapter: Appendix A: Workshop Statement of Task and Agenda

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Suggested Citation:"Appendix A: Workshop Statement of Task and Agenda." Institute of Medicine. 2013. Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18362.
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A

Workshop Statement of Task and Agenda

Implementing a National Cancer Clinical Trials System for the 21st Century, Second Workshop

Hosted by the American Society of Clinical Oncology and the Institute of Medicine’s National Cancer Policy Forum

STATEMENT OF TASK

An ad hoc committee will plan and conduct a public workshop to identify and examine ongoing activities to implement the recommendations put forth in the Institute of Medicine (IOM) consensus report A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. The first workshop (to be held in early 2011) would invite all stakeholders charged with making changes to the system (e.g., National Cancer Institute [NCI], Food and Drug Administration [FDA], Office for Human Research Protections [OHRP], Centers for Medicare & Medicaid Services [CMS], NCI Cooperative Group Chairs, drug/biotech/device industry, patient advocates, investigators at academic and community sites, and private payers) to discuss what changes they plan to implement in response to the IOM recommendations. The second workshop (to be held in 2013) would reconvene the stakeholders to discuss progress made to date and to identify additional actions to take. Individually authored summaries of the workshops will subsequently be prepared by a designated rapporteur.

Suggested Citation:"Appendix A: Workshop Statement of Task and Agenda." Institute of Medicine. 2013. Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18362.
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February 11, 2013

7:30 am Registration
 
8:15 am Welcome from the IOM’s National Cancer Policy Forum
  • John Mendelsohn, MD Anderson Cancer Center, Chair, National Cancer Policy Forum

Introduction to the Workshop
  • Monica Bertagnolli, Alliance for Clinical Trials in Oncology and Dana-Farber Cancer Institute (DFCI), Workshop Planning Committee Chair
 
8:25 am Session 1: Updates from NCI and the National Clinical Trials Network (NCTN) Components: Progress to Date
Moderator: James Doroshow, NCI

NCI Updates
  • James Doroshow, NCI Division of Cancer Treatment and Diagnosis

Updates from the Cooperative Groups
  • Robert Comis, ECOG-ACRIN Cancer Research Group

Updates on the Community Clinical Oncology Programs (CCOPs)/NCI Community Cancer Centers Program/NCI Community Oncology Research Program (NCORP)
  • Worta McCaskill-Stevens, NCI Division of Cancer Prevention

Panel Discussion
Speakers above plus representatives of community practices in the NCORP:
  • Stephen Grubbs, Helen F. Graham Cancer Center and Christiana Care CCOP
  • Robin Zon, Michiana Hematology-Oncology, and Northern Indiana Cancer Research Consortium CCOP
 
10:00 am Break
Suggested Citation:"Appendix A: Workshop Statement of Task and Agenda." Institute of Medicine. 2013. Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18362.
×
 
10:15 am Session 2: Funding for Cancer Clinical Trials
Moderator: John Mendelsohn, MD Anderson Cancer Center

Metrics on Technical Risks, Clinical Development Times and Approval Times for Cancer Drugs
  • Joseph DiMasi, Tufts Center for the Study of Drug Development

Funding Clinical Trials in the Academic and Community Research Environment
  • Marc Sabatine, Thrombolysis in Myocardial Infarction Study Group

Foundation Perspective
  • Margaret Anderson, FasterCures

Panel Discussion
 
11:45 am Lunch Break
 
12:30 pm Session 3: Prioritization of Cancer Trials in a Changing Environment
Moderator: George Sledge, Stanford University School of Medicine

Status Report from the CTAC Strategic Planning Subcommittee
  • George Sledge, Stanford University School of Medicine
  • Robert Diasio, Mayo Clinic Cancer Cente

An International Perspective from the UK Network on Prioritization of Trials:
  • Richard Kaplan, UK National Cancer Research Network & Medical Research Council

Panel Discussion
Suggested Citation:"Appendix A: Workshop Statement of Task and Agenda." Institute of Medicine. 2013. Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18362.
×
 
1:45 pm Session 4: The NCTN as a Platform to Implement Precision Medicine
Moderator: Barbara Conley, NCI Division of Cancer Treatment and Diagnosis

Resources Needed for a Trial Employing Genomic Profiling for Eligibility
  • Levi Garraway, DFCI

Information from “Exceptional Responders” and the Implementation of Basket Trials
  • David Solit, Memorial Sloan-Kettering Cancer Center

Challenges in Real-World Implementation of Genomic Profiling for Eligibility in Broad, National Clinical Trials
  • Vincent Miller, Foundation Medicine

Investigational Device Exemption Requirements for Diagnostic Tests Used in Clinical Trials
  • John Jessup, Diagnostics Evaluation Branch, NCI Division of Cancer Treatment and Diagnosis

Panel Discussion
 
3:45 pm Break
 
4:00 pm Panel Discussion
Moderator: Michael Caligiuri, Ohio State University Comprehensive Cancer Center

Panelists:
Cooperative Group Chairs
  • Charles Blanke, SWOG
  • Robert Comis, ECOG-ACRIN
  • Peter Adamson, Children’s Oncology Group
  • Walter Curran, NRG Oncology Group
NCI
  • James Doroshow, NCI Division of Cancer Treatment and Diagnosis
Suggested Citation:"Appendix A: Workshop Statement of Task and Agenda." Institute of Medicine. 2013. Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18362.
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FDA
  • Richard Pazdur, FDA Office of Hematology and Oncology Products
Patient Advocates
  • Nancy Roach, Fight Colorectal Cancer
  • Patrick Gavin, Patrick Gavin R.Ph. Consulting LLC
 
5:30 pm Wrap Up Day 1 and Adjourn

February 12, 2013

7:30 am Registration
 
8:00 am Session 5: Accelerating Innovation Through Effective Partnerships
Moderator: Monica Bertagnolli, Alliance for Clinical Trials in Oncology and DFCI

Comprehensive Cancer Center Perspectives
  • Edward Benz, DFCI

Industry Perspective
  • Renaud Capdeville, Novartis Oncology

International Perspective: NEWDIGS Initiative, Massachusetts Institute of Technology Center for Biomedical Innovation
  • Hans-Georg Eichler, European Medicines Agency (EMA)

Accelerating Innovation in Statistical Design
  • Lisa McShane, NCI Division of Cancer Treatment and Diagnosis

Partnering with Advocates
  • Patrick Gavin, Patrick Gavin R.Ph. Consulting LLC

Panel Discussion
Suggested Citation:"Appendix A: Workshop Statement of Task and Agenda." Institute of Medicine. 2013. Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18362.
×
 
10:45 am Break
 
11:00 am Session 6: Regulatory Issues
Moderator: Richard L. Schilsky, American Society of Clinical Oncology (ASCO)

Optimizing Safety Data Collection in Cancer Clinical Trials
  • Richard L. Schilsky, ASCO

FDA Perspective on Data Quality Issues
  • Rachel Sherman, FDA Office of Medical Policy

The Role of the Cancer Therapy Evaluation Program/NCI in Registration Trials
  • Jeffrey Abrams, NCI Division of Cancer Treatment and Diagnosis

FDA/NCI Collaboration—Independent Radiologic Review
  • Lori Dodd, NCI Biostatistics Research Branch

Pharmaceutical Industry
  • Sandra Horning, Genentech

EMA-FDA Harmonization
  • Francesco Pignatti, EMA

Panel Discussion
Speakers plus:
  • Robert Iannone, Merck Research Laboratories
  • Debasish Roychowdhury, Sanofi Oncology
 
1:45 pm Workshop Wrap-Up
  • Monica Bertagnolli, Alliance for Clinical Trials in Oncology and DFCI
 
2:00 pm Adjourn
Suggested Citation:"Appendix A: Workshop Statement of Task and Agenda." Institute of Medicine. 2013. Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18362.
×
Page 83
Suggested Citation:"Appendix A: Workshop Statement of Task and Agenda." Institute of Medicine. 2013. Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18362.
×
Page 84
Suggested Citation:"Appendix A: Workshop Statement of Task and Agenda." Institute of Medicine. 2013. Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18362.
×
Page 85
Suggested Citation:"Appendix A: Workshop Statement of Task and Agenda." Institute of Medicine. 2013. Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18362.
×
Page 86
Suggested Citation:"Appendix A: Workshop Statement of Task and Agenda." Institute of Medicine. 2013. Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18362.
×
Page 87
Suggested Citation:"Appendix A: Workshop Statement of Task and Agenda." Institute of Medicine. 2013. Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18362.
×
Page 88
Next: Appendix B: Executive Summary of *A National Cancer Clinical Trials System for the 21st Century* »
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The National Clinical Trials Network (NCTN) supported by the National Cancer Institute (NCI) has played an integral role in cancer research and in establishing the standard of care for cancer patients for more than 50 years. Formerly known as the NCI Clinical Trials Cooperative Group Program, the NCTN is comprised of more than 2,100 institutions and 14,000 investigators, who enroll more than 20,000 cancer patients in clinical trials each year across the United States and internationally.

Recognizing the recent transformative advances in cancer research that necessitate modernization in how cancer clinical trials are run, as well as inefficiencies and other challenges impeding the national cancer clinical trials program, the NCI asked the IOM to develop a set of recommendations to improve the federally funded cancer clinical trials system. These recommendations were published in the 2010 report, A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program.
In early 2011, the NCPF and the American Society of Clinical Oncology (ASCO) held a workshop in which stakeholders discussed the changes they planned to implement in response to the IOM goals and recommendations. Two years later, on February 11-12, 2013, in Washington, DC, the NCPF and ASCO reconvened stakeholders to report on the changes they have made thus far to address the IOM recommendations. At this workshop, representatives from the NCI, the NCTN, comprehensive cancer centers, patient advocacy groups, the Food and Drug Administration (FDA), industry, and other stakeholders highlighted the progress that has been made in achieving the goals for a reinvigorated national cancer clinical trials system. Implementing a National Cancer Clinical Trials System for the 21st Century is a summary of that workshop.
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