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A Workshop Agenda March 21, 2011, Agenda The Keck Center of the National Academies 500 Fifth Street, NW Washington, DC 20001 Room 100 PURPOSE In April 2010, an IOM consensus report entitled A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Coopera- tive Group Program was released to the public. The authoring committee concluded that: Collectively, the implementation of [the committee’s] recommendations would reinvigorate the Clinical Trials Cooperative Group Program for the 21st century and strengthen its position as a critical component of the trans- lational pathway from scientific discovery to improved treatment outcomes for patients with cancer. Modifying any particular element of the Program or the clinical trials process will not suffice; changes across the board are urgently needed. All participants and stakeholders, including physicians, patients, and health care insurers, as well as NCI, other federal agencies, academia, founda- tions, and industry, must reevaluate their current roles and responsibilities in cancer clinical trials and work together to develop a more effective and efficient multidisciplinary trials system. 99

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100 IMPLEMENTING A NATIONAL CANCER CLINICAL TRIALS SYSTEM Because of the necessity for diverse stakeholders to work toward a common goal, this workshop (and one to follow in 2012) will convene stakeholders for discussions of how best to achieve the aims underlying the IOM recommendations and to summarize progress thus far. WORKSHOP GOALS The goals of the workshops are to: 1. Establish a venue to promote a collaborative approach by all stake- holders to implement recommended changes; 2. Provide a forum to ensure public involvement; 3. Document changes that take place; and 4. Facilitate progress toward the IOM committee’s goal of ensuring the continued viability and increased productivity of an NCI-funded clinical trials system with widespread academic involvement and community outreach. March 21, 2011 7:30 am Breakfast and Registration 8:00 am Welcome and Opening Remarks National Cancer Policy Forum Chair 8:15 am Panel 1: National Cancer Institute and the Cooperative Groups Moderator: Richard L. Schilsky, University of Chicago, Workshop Chair NCI Perspective and Current Activities

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101 APPENDIX A 8:45 am Cooperative Group Leadership Perspective and Current Activities Statistical Center 9:15 am Experience from the Consolidation of COG past chair, Children’s Oncology Group 9:30 am Roundtable Discussion with Presenters and Cooperative Group Leadership Group Bowel Project Imaging Network Group Network Bowel Project 10:45 am Break

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102 IMPLEMENTING A NATIONAL CANCER CLINICAL TRIALS SYSTEM 11:00 am Panel 2: Payors Moderator: Lee Newcomer, UnitedHealthCare Opening Remarks – Sharon Levine, Kaiser Permanente – James Cross, AETNA – Louis Jacques, CMS enrollment in a trial – Karen Hagerty, Director of Reimbursement Policy, ASCO Cancer Policy and Clinical Affairs Department 11:45 am Panel Discussion 12:30 pm Pick up Lunch and Return for Panel 3 1:00 pm Panel 3: Interactions Between Industry, the FDA, and the Publicly-Funded Cancer Clinical Trials System Moderator: John Hohneker, Novartis Pharmaceuticals Opening Remarks – Ira Steinberg, Sanofi-Aventis U.S. and CEO Roundtable on Cancer Life Sciences Consortium – Steven Shak, Genomic Health – Richard Pazdur, Center for Drug Evaluation and Research – Glen de Vries, Medidata Solutions 1:30 pm Panel Discussion Include presenters and:

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103 APPENDIX A 3:00 pm Break 3:15 pm Panel 4: Clinical Trials Investigators and Patient Advocates Moderator: Jan Buckner, North Central Cancer Treatment Group Opening Remarks 2009 NCI Clinical Team Leadership Awardee 4:00 pm Panel Discussion 5:15 pm Closing Comments/Wrap Up Richard L. Schilsky 5:30 pm Adjourn

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