Notice Number: NOT-CA-08-023
Release Date: June 11, 2008
National Cancer Institute (NCI) (http://www.cancer.gov/)
The National Cancer Institute's Early Detection Research Network (EDRN; http://edrn.nci.nih.gov/) announces its continued support for collaborative research on biomarker validations for risk assessment and early detection under the Program for Rapid, Independent Diagnostic Evaluation (PRIDE; http://edrn.nci.nih.gov/colops/pride.pdf). PRIDE serves as an administrative means to assist extramural investigators in the conduct of cross-laboratory validations of biomarkers. These efforts may include the development, refinements, and uses of new and existing assays, reagents, methods, and tests.
Background on the EDRN
Established in 2000, the EDRN and its participants are focused on translating new advances at the molecular levels into practical clinical tests to: detect cancers at the earliest stages of neoplastic transformations; and identify individuals at risk of developing cancer.
The EDRN consists of the following four main components:
The EDRN supports studies on the development and clinical validations of biomarkers, and the creation of standard operating procedures for assays, methodologies, and sample preparations. The EDRN resources include organ-specific serum reference samples, technologies, informatics, and reference laboratories on validation. Through these resources, EDRN supports investigators by helping them with rapid evaluations of the reproducibility, portability, and precision of their technologies and biomarker assays. EDRN investigators are also developing a number of models for risk assessments, such as the Prostate Risk Calculator (go to http://www.compass.fhcrc.org/edrnnci/bin/calculator/main.asp?t=prostate&sub=disclaimer&v=prostate&m=&x=Prostate%20Cancer). Researchers may seek support and participate in the field evaluation of such calculators.
Submitting Requests for Biomarker Validation under PRIDE
Interested investigators are invited to submit Request-for-Validation-Support letters for their biomarkers that meet the criteria for Phase II or Phase III validations as described in the Journal of the National Cancer Institute 93(4), 1054 -1061, 2001.
Request-for-Validation-Support letters containing descriptions of biomarkers meeting the eligibility criteria (up to 2-3 pages) are accepted on a continuous basis throughout the year (see the contact address below).
There is no restriction on the number of these requests. However, a separate Request-for-Validation-Support letter will be required for each organ site (i.e., for the one or more biomarkers that are proposed for validation studies in association with cancer of a specific organ site).
If selected, an investigator will be invited to present the proposed biomarker validation study (or studies) to the relevant EDRN Collaborative Group as part of the further evaluation. Funding for PRIDE will be provided through the EDRN's set-aside funds for biomarker validations.
For further details on PRIDE and for information regarding the format and special requirements of the request-for-validation-support letters, go to the NCI's Request-for-Biomarkers web site at http://edrn.nci.nih.gov/colops.
We encourage your inquiries concerning this program and welcome the opportunity to answer questions from potential applicants. Inquiries and Request-for-Validation-Support letters should be directed to:
Mr. Donald Johnsey
Division for Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 3148, MSC 7362
Bethesda, MD 20892-7362 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 435-5015
Fax: (301) 402-8990
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Office of Extramural
National Institutes of Health (NIH)
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Department of Health
and Human Services (HHS)