This grant will provide support for the Statistics and Data Management Center (SDMC) of the ECOG- ACRIN Cancer Research Group. The SDMC is organized and operated jointly by the Department of Biostatistics and Computational Biology at the Dana-Farber Cancer Institute (DFCI), the Department of Biostatistics at Brown University, the ECOG-ACRIN Medical Research Foundation (EAMRF), and the American College of Radiology (ACR), under the direction of the Group Statisticians. The primary responsibility for data collection and management belongs to the Data Management Center, consisting of EAMRF and ACR. The primary responsibility for study design, monitoring, and analysis, and for overseeing and coordinating SDMC operations, belongs to the Biostatistics Center, consisting of DFCI and Brown University. The primary contact site for grant administration is DFCI. ECOG-ACRIN is a multi-modality group conducting a wide range of studies, including definitive phase III trials of therapeutic interventions, earlier phase studies developing new therapies, studies focused on diagnosis and of advanced imaging methods, investigation of laboratory and imaging based biomarkers, and studies incorporating patient reported outcomes. The SDMC is responsible for all quantitative aspects of EA's activities. Our overall goals are to conduct clinical trials to the highest standards in statistical methods, data management, and regulatory compliance, while continually improving efficiency of all of our processes and systems to optimize the use of our limited resources. Areas of particular focus in this grant include studies incorporating tissue and imaging biomarkers to direct therapy, studies of immunotherapy, studies of de-intensification of therapy to reduce morbidity, studies investigating novel biomarkers, and studies investigating the relationship of biomarkers and therapy in populations defined by race, ethnicity, gender, and age.

The overall purpose of this grant is to provide expertise in statistics and data management to support the research mission of the ECOG-ACRIN Cancer Research Group. Achievement of our objectives will enable ECOG-ACRIN to continue to produce high quality clinical studies that advance the care of cancer patients.