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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.



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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. Individu- ally authored summaries of the workshops will subsequently be prepared by a designated rapporteur. 83

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84 IMPLEMENTING A NATIONAL CANCER CLINICAL TRIALS SYSTEM 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 •  onica Bertagnolli, Alliance for Clinical Trials in M 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 •  ames Doroshow, NCI Division of Cancer Treatment J 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) •  orta McCaskill-Stevens, NCI Division of Cancer W Prevention Panel Discussion Speakers above plus representatives of community practices in the NCORP: •  tephen Grubbs, Helen F. Graham Cancer Center and S Christiana Care CCOP •  obin Zon, Michiana Hematology-Oncology, and R Northern Indiana Cancer Research Consortium CCOP 10:00 am Break

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APPENDIX A 85 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 •  oseph DiMasi, Tufts Center for the Study of Drug J Development Funding Clinical Trials in the Academic and Community Research Environment •  arc Sabatine, Thrombolysis in Myocardial Infarction M 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 Center  International Perspective from the UK Network on An Prioritization of Trials: •  ichard Kaplan, UK National Cancer Research R Network & Medical Research Council Panel Discussion

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86 IMPLEMENTING A NATIONAL CANCER CLINICAL TRIALS SYSTEM 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 •  ohn Jessup, Diagnostics Evaluation Branch, NCI J 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 •  alter Curran, NRG Oncology Group W NCI •  ames Doroshow, NCI Division of Cancer Treatment J and Diagnosis

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APPENDIX A 87 FDA •  ichard Pazdur, FDA Office of Hematology and R 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 •  ans-Georg Eichler, European Medicines Agency H (EMA) Accelerating Innovation in Statistical Design •  isa McShane, NCI Division of Cancer Treatment and L Diagnosis Partnering with Advocates • Patrick Gavin, Patrick Gavin R.Ph. Consulting LLC Panel Discussion

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88 IMPLEMENTING A NATIONAL CANCER CLINICAL TRIALS SYSTEM 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 •  effrey Abrams, NCI Division of Cancer Treatment and J 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 •  onica Bertagnolli, Alliance for Clinical Trials in M Oncology and DFCI 2:00 pm Adjourn