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Implementing a National Cancer Clinical Trials System for the 21st Century Second Workshop Summary (2013) / Chapter Skim
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Appendix A: Workshop Statement of Task and Agenda
Pages 83-88

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From page 83...
... 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]
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From page 84...
... 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)
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From page 85...
... 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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From page 86...
... 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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From page 87...
... 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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From page 88...
... 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
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Key Terms

  • cancer clinical
  • cancer center
  • nci division
  • cancer treatment
  • panel discussion

  • cancer research
  • onica bertagnolli
  • nci cooperative
  • clinical oncology
  • ames doroshow

  • robert comis
  • indiana cancer
  • community cancer
  • graham cancer
  • research protections

  • iom recommendations
  • human research
  • nci updates
  • lori dodd
  • consulting llc

  • consortium ccop
  • biostatistics research
  • optimizing safety
  • oncology research
  • cancer centers

  • community sites
  • obin zon
  • research branch
  • medicaid services
  • private payers


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