Consortium on Translational Research in Early Detection of Liver Cancer:Data Management and Coordinating Center (DMCC)

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PROJECT SUMMARY ABSTRACT The key to success of the Consortium on Translational Research in Early Detection of Liver Cancer (Consortium) lies in good communication among scientists in multiple disciplines, efficient evaluation and prioritization of promising biomarkers, and rigorous validation studies to demonstrate their potential clinical utilities in improving the surveillance and early detection of liver cancer and stratifying the risk of liver cancer in patients with cirrhosis. The overall aims of the proposed Data Management and Coordinating Center (DMCC) are to (i) enhance communication and collaboration among Consortium investigators; (ii) coordinate Consortium collaborative research and provide statistical support; (iii) develop and maintain integrated research and biorepository databases for Consortium studies; and (iv) support and facilitate trans-Consortium collaborative research. Under the direction of the Consortium Steering Committee, the DMCC will 1) perform network coordination and promote collaborations among scientific investigators by providing support for Consortium meetings and conference calls, developing and maintaining all Consortium documents, including the Manual of Operations and Procedures (MOP), and by maintaining and enhancing the Consortium’s secure website; 2) support Consortium collaborative studies by working with Consortium investigators on study design, protocol development, data forms, and study manuals; coordinating and monitoring studies; tracking specimen sharing, blinding, and randomization; and performing QA/QC and study evaluation; 3) maintain and enhance the COMPASS Data Management System (CDMS) used to facilitate Consortium collaborative activities. CDMS provides online, end- to-end data management solutions, including investigator and study coordinator communications, regulatory compliance, remote subject registration, clinical data capture, biospecimen sample management, imaging data repository, and document management. CDMS can provide online visibility of analytical datasets for all participating researchers, and statistical and informatic tools relevant to Consortium research; 4) support and facilitate trans-Consortium collaborative studies by promoting team science, monitoring study procedures, and using cutting edge statistical, computational, and Artificial Intelligence methods to ensure efficient yet rigorous study design and maximize research outputs. Our research strategy is built from this guiding principle: provide the highest quality service to the Consortium while remaining innovative and providing scientific leadership to help the Consortium achieve its mission. Our qualifications include being the DMCC for the Early Detection Research Network since its inception, serving as lead statisticians for the two largest ongoing cirrhosis cohort studies in this country, and being responsible for two FDA-cleared Imaging AI products and many statistical innovations in early detection research.