Notice Number: NOT-CA-09-014
Release Date: February 4, 2009
National Cancer Institute (NCI), (http://www.cancer.gov)
This Request for Information (RFI) is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and the National Cancer Institute (NCI). The NCI does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.
The purpose of this RFI is to gather information from the scientific community about the opportunity to identify priorities for biomarker discovery and validation research to be conducted under the auspices of the NCI’s Early Detection Research Network (EDRN; www.cancer.gov/edrn). The EDRN is a consortium funded through the NIH cooperative agreement mechanism under programmatic oversight provided by the NCI. Information submitted in response to this RFI may be used to help NCI Program Officials identity future directions for this Network.
Feedback is sought from the following sources:
The mission of the EDRN is to discover, develop and validate biomarkers for cancer risk assessment, early detection, early diagnosis and prognosis and to coordinate biomarker research with therapeutic strategies. These goals are achieved through translational research and implementation of strategic and systematic evidence-based biomarker research. The EDRN was conceived on the premise that a “vertical” approach to biomarker research with an established integrated, multidisciplinary environment will expedite clinical applications of molecular knowledge. The EDRN provides an infrastructure and environment that fosters translational research by encouraging collaborations among basic scientists, population-based scientists, and physician scientists with expertise in clinical applications.
The EDRN consists of the following four main components:
The EDRN has focused on cancers where biomarkers have a high potential to reduce cancer morbidity and mortality. In this regard, the EDRN targets mainly the major epithelial cancers and has established collaborative groups for each of the major organ systems (www.cancer.gov/edrn).
Although numerous potential biomarkers are identified every year, few have been validated for clinical use. Most candidate biomarkers fail to meet the rigorous statistical requirements for intended clinical use (Pepe MS et al., JNCI 100:1432-8; 2008). Difficulties in the identification and development of clinically useful biomarkers have been attributed, in part, to the poor quality of samples used for discovery, inappropriate study designs (which failed to account for confounders and bias), and insufficient infrastructure to support the translation of potential biomarker discovery into clinical tests. The currently funded EDRN is taking measures to overcome these obstacles by supporting biomarker research that meets the requirements of sample quality, study design, statistical rigor, and clinical endpoints (see EDRN Fourth; www.cancer.gov/edrn). However, in anticipation of the continuation of the EDRN Program, the NCI is seeking input from the community on all facets of biomarker discovery, development and validation and on development of biomarker-based clinical tests.
This RFI solicits information on biomarkers for cancer risk assessment, early detection, early diagnosis, and prognosis that the EDRN can use to enable and/or expedite the development and validation of biomarkers into clinical tests that can benefit patients. Information provided to the NCI may be used in formulating the re-issuance of the EDRN Request for Applications (RFAs).
Please provide concise responses in the context of biomarkers to any or all of the following topics (do not exceed 3 pages):
Please indicate which type of institution or organization you are primarily affiliated with (using the following categories):
How to Respond?
Responses will be accepted until March 30, 2009. Responses should be limited to three pages and marked with this RFI identifier NOT-CA-09-014. Responses are preferred in electronic format and can be e-mailed to email@example.com.
Respondents will receive an email confirmation acknowledging receipt of their response, but will not receive individualized feedback.Responses to this RFI are voluntary and may be anonymous. All individual responses will remain confidential. Any identifiers (e.g., names, institutions, e-mail addresses, etc) will be removed when responses are compiled. Only the processed, anonymized results will be shared internally with scientific working groups convened by the NCI, as appropriate. Nonetheless, no proprietary information should be submitted.
Inquiries regarding this Notice may be directed to:
Sudhir Srivastava, Ph.D., MPH
Chief, Cancer Biomarkers Research Group
National Cancer Institute
6130 Executive Boulevard, EPN Suite 3142
Bethesda, MD 20892-7362
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