) Emerging scientific technologies that explore early cancer detection and assessment are of paramount importance in the effort toward reducing mortality from cancer. However, the approach to the development of biomarkers for early cancer detection bas been fragmented and not well coordinated. The charge of the Early Detection Research Network (EDRN) is to discover and coordinate the evaluation of biomarkers/reagents for the early detection of cancer and for the assessment of risk through scientific collaboration, knowledge sharing, and overall coordination of activities. The overall aim of the proposed Data Management and Coordinating Center (DMCC) is to provide coordination and data management for the EDRN under the direction of the Steering Committee, and to develop statistical and analytical methods useful for basic, translational, and clinical research in biomarkers for early detection of cancer. Under the direction of the Steering Committee, the DMCC will 1) perform network coordination and develop collaborations with other scientific components of the network by producing the Network Operations Policy and Procedure Manuals, assisting in the development and implementation of collaborative study research protocols, analyzing data from collaborative studies and providing statistical consultation for center-specific studies in EDRN, developing and maintaining a web page and listserv, promoting interactions between the EDRN and other relevant networks and consortia, and providing logistical and administrative support for network meetings; 2) provide data management support for collaborative studies in EDRN by developing data collection protocols and monitoring adherence, developing and maintaining collaborative study databases, and providing reports and study data as needed; 3) develop statistical and analytical methods for biomarker evaluation and interpretation, with emphasis on flexible descriptive statistical methods for a) assessing the reliability and reproducibility of biomarkers and identifying factors which contribute to reduced reliability; b) assessing the accuracy of biomarkers for cancer detection or cancer risk assessment, and factors influencing their diagnostic potential both when a gold standard exists and when it does not exist; c) combining multiple biomarkers; d) identifying cancer heterogeneity by biomarkers; and e) identifying biomarkers; from microarray expression data.
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