The purpose of this FOA is to solicit applications for Clinical Validation Centers (CVCs); one of the three scientific units of the Early Detection Research Network (EDRN). EDRN (http://edrn.nci.nih.gov/) is an integrated infrastructure to develop and validate biomarkers and imaging methods for the detection of early stage cancers and risk assessment. Clinical Validation Centers (CVCs) will conduct research to validate biomarkers and/or imaging methods for risk assessment and detection of early stage cancers. CVCs will also serve as resource centers for collaborative research within the EDRN by providing high-quality specimens for phase 1 and 2 biomarker refinement studies to other EDRN scientific units, as well as for conducting Network collaborative biomarker validation studies. The CVCs must also have the expertise and ability to conduct Phase 4 clinical utility trials of validated early detection biomarkers and/or imaging methods.
The other two scientific units of the EDRN are the Biomarker Characterization Centers (BCCs), which will (1) discover, develop, characterize and test new biomarkers or refine existing biomarkers, (2) develop, refine and/or standardize biomarker assays, (3) provide resources and support for the validation of biomarkers developed by the EDRN, and (4) participate in collaborative projects with other laboratories and centers; and the Data Management and Coordinating Center (DMCC), which will support statistical and computational analyses, informatics infrastructure, study design, coordination and management of EDRN-sponsored biomarker validation studies, and the coordination of Network-wide meetings and workshops.