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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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