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 Cooperative 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 translational 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, foundations, 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.
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 stakeholders 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
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7:30 am |
Breakfast and Registration |
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8:00 am |
Welcome and Opening Remarks • Richard L. Schilsky, University of Chicago, Workshop Chair • John Mendelsohn, M.D. Anderson Cancer Center, National Cancer Policy Forum Chair |
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8:15 am |
Panel 1: National Cancer Institute and the Cooperative Groups Moderator: Richard L. Schilsky, University of Chicago, Workshop Chair |
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NCI Perspective and Current Activities • James Doroshow, Division of Cancer Treatment and Diagnosis • Lori Minasian, Division of Cancer Prevention |
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8:45 am |
Cooperative Group Leadership Perspective and Current Activities • Jan Buckner, North Central Cancer Treatment Group • Robert Gray, Eastern Cooperative Oncology Group Statistical Center |
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9:15 am |
Experience from the Consolidation of COG • Greg Reaman, Children’s National Medical Center, and past chair, Children’s Oncology Group |
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9:30 am |
Roundtable Discussion with Presenters and Cooperative Group Leadership • Peter Adamson, Children’s Oncology Group • Karla Ballman, American College of Surgeons Oncology Group • Monica Bertagnolli, Cancer and Leukemia Group B • John Blessing, Gynecologic Oncology Group • Robert Comis, Eastern Cooperative Oncology Group • Joseph Costantino, National Surgical Adjuvant Breast and Bowel Project • John J. Crowley, Southwest Oncology Group • Walter Curran, Radiation Therapy Oncology Group • James Dignam, Radiation Therapy Oncology Group • Philip DiSaia, Gynecologic Oncology Group • Constantine Gatsonis, American College of Radiology Imaging Network • Sin-Ho Jung, Cancer and Leukemia Group B • Heidi Nelson, American College of Surgeons Oncology Group • David Ota, American College of Surgeons Oncology Group • Mitchell Schnall, American College of Radiology Imaging Network • Norman Wolmark, National Surgical Adjuvant Breast and Bowel Project |
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10:45 am |
Break |
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11:00 am |
Panel 2: Payors Moderator: Lee Newcomer, UnitedHealthCare |
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Opening Remarks • Insurers – Sharon Levine, Kaiser Permanente – James Cross, AETNA • Centers for Medicare and Medicaid Services – Louis Jacques, CMS • Charles Rudin, Johns Hopkins University • Process for establishing a new CPT code for patient enrollment in a trial – Karen Hagerty, Director of Reimbursement Policy, ASCO Cancer Policy and Clinical Affairs Department |
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11:45 am |
Panel Discussion |
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12:30 pm |
Pick up Lunch and Return for Panel 3 |
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1:00 pm |
Panel 3: Interactions Between Industry, the FDA, and the Publicly-Funded Cancer Clinical Trials System Moderator: John Hohneker, Novartis Pharmaceuticals |
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Opening Remarks • Pharmaceutical industry – Ira Steinberg, Sanofi-Aventis U.S. and CEO Roundtable on Cancer Life Sciences Consortium • Diagnostic industry – Steven Shak, Genomic Health – Richard Pazdur, Center for Drug Evaluation and Research • Informatics vendor – Glen de Vries, Medidata Solutions |
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1:30 pm |
Panel Discussion Include presenters and: • Jerry Menikoff, Office for Human Research Protections • Robert Becker, Center for Devices and Radiological Health |
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3:00 pm |
Break |
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3:15 pm |
Panel 4: Clinical Trials Investigators and Patient Advocates Moderator: Jan Buckner, North Central Cancer Treatment Group |
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Opening Remarks • Michael Caligiuri, Association of American Cancer Institutes • Maria Gonzalez NCCCP St. Joseph Hospital of Orange • Stephen Grubbs, Community Clinical Oncology Program • Michael Katz, Cooperative Group advocate • Shelley Fuld Nasso, Susan G. Komen for the Cure • Melanie Thomas, Medical University of South Carolina, 2009 NCI Clinical Team Leadership Awardee |
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4:00 pm |
Panel Discussion |
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5:15 pm |
Closing Comments/Wrap Up Richard L. Schilsky |
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5:30 pm |
Adjourn |
