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.
February 11, 2013
7:30 am | Registration |
8:15 am |
Welcome from the IOM’s National Cancer Policy Forum
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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
Speakers above plus representatives of community practices in the NCORP:
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10:00 am | Break |
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
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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
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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
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3:45 pm | Break |
4:00 pm |
Panel Discussion Moderator: Michael Caligiuri, Ohio State University Comprehensive Cancer Center Panelists: Cooperative Group Chairs
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FDA
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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
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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
Speakers plus:
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1:45 pm |
Workshop Wrap-Up
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2:00 pm | Adjourn |