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Project Title:
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Cancer Clinical Trials and the NCI Cooperative Group Program
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PIN:
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IOMX-H-08-06-A
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Major Unit:
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Institute of Medicine
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Sub Unit:
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Board on Health Care Services
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RSO:
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Nass, Sharyl
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Subject/Focus Area:
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Health and Medicine
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Project Scope
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An IOM committee will review the organization and operation of the National Cancer Institute (NCI) Cooperative Group Program and recommend ways to improve the quality of cancer clinical trials conducted by the Groups. Attention will be focused on how to improve, modernize and streamline the process, with special consideration given to the recent emphasis on targeted therapies due to an improved understanding of the biology of cancer. Given the limits on funding for cancer clinical trials, there is a particular need to improve efficiency and make efficient use of time, effort, and resources. Specifically, the committee will recommend ways to:
- Improve the design, review, and operation of clinical trials
- Reduce the prolonged period of time currently spent moving from initial concept to final approval
- Prioritize trials and trial sites based on scientific merit and past performance
- Increase participation of both clinicians and patients
- Make greater use of technologies such as imaging and biomarkers to select therapies for development and testing, to match patients and therapies, and to monitor patient responses
- Define standards for minimal data requirements to establish safety and efficacy of experimental therapies
- Reduce costs and ensuring adequate funds for high quality trials
- Promote greater collaboration among various stakeholders
SPONSORS:
- the Centers for Disease Control and Prevention (CDC)
- the Food and Drug Administration (FDA)
- the National Cancer Institute (NCI)
- the American Society of Clinical Oncology (ASCO)
- the Association of American Cancer Institutes (AACI)
- C-Change
The approximate starting date for the project is 12/01/2008.
A Final Report will be issued at the end of the project in approximately 16 months.
Project Duration: 16 Months.
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Project Duration:
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16 months
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Provide FEEDBACK on this project.
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Contact the Public Access Records Office to make an inquiry, request a list of the public access file materials, or obtain a copy of the materials found in the file.
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Tel:
202.334.2000