The Early Detection Research Network (EDRN) is a national network funded in 1999 for the development, evaluation, and validation of biomarkers for early detection and risk assessment for cancer. Biomarkers are cellular, biochemical, molecular, or genetic alterations by which a normal or abnormal biologic process can be recognized or monitored. Biomarkers are measurable in biological media, such as fluids, tissues, or cells. In addition to the National Cancer Institute (NCI), which funds the EDRN, there are four components to the network: Biomarker Development Laboratories, Biomarker Validation Laboratories, Clinical Validation Centers, and a Data Management and Coordinating Center (DMCC). Under the direction of Principal Investigators Ziding Feng, Ph.D., Mark Thornquist, Ph.D., and Margaret Pepe, Ph.D., the DMCC provides logistical, informatics, and statistical services to the EDRN.
The EDRN DMCC, funded in 2000, provides logistical support and coordination for 59 institutions in EDRN; coordinates meetings, conference calls, and workshops; develops and manages the EDRN secure website; develops and maintains, in collaboration with the Jet Propulsion Laboratories, the EDRN Research Network Exchange (ERNE); participates in the review of validation studies and associate member applications; manages and coordinates EDRN validation studies; develops and maintains the Validation Study Information Management System (VSIMS) for data collection and management; specimen tracking and study monitoring; and conducts statistical methodology research for EDRN.
The DMCC, operated by the Fred Hutch, the University of Washington and the University of Texas MD Anderson Cancer Center statisticians and COMPASS, provides coordination and data management for the EDRN under the direction of the Steering Committee and develops statistical and analytical methods in response to the scientific needs of the network. Specific tasks performed by at the DMCC include:
- Network Coordination. Produce Operating Policy and Procedure Manuals, assist in the development and implementation of collaborative study research protocols, develop and maintain a network secure website and listserv, provide logistical and administrative support for meetings, and provide statistical support for collaborative studies within the network and statistical consultation to center-specific studies.
- Data Management. Provide data management support for collaborative studies in the network, including developing data collection protocols, monitoring adherence, developing and maintaining databases, and providing reports or study data as needed.
- Theoretical and Applied Research. Develop statistical and analytical methods for biomarker evaluation and interpretation, specifically focusing on the development and evaluation of flexible descriptive statistical methods 1) to assess the reliability and reproducibility of biomarkers and to identify factors that contribute to reducing reliability, 2) to assess the accuracy of a biomarker for cancer detection or cancer risk assessment, and factors influencing its diagnostic potential, both when a gold standard exists, and when one does not, 3) to identify cancer heterogeneity for specific biomarkers, and 4) to identify biomarkers from microarray expression data.