Alliance Statistics and Data Management Center

Alliance Statistics and Data Management Center: Overall Core PROJECT SUMMARY The Alliance for Clinical Trials in Oncology (Alliance) is a National Cancer Institute (NCI) funded National Clinical Trials Network (NCTN) that efficiently develops and manages phase II and phase III clinical and translational trials, as well as selected earlier phase development trials, from concept generation to timely completion, publication and data sharing. The Alliance Statistics and Data Management Center (SDMC), under the leadership of Dr. Sumithra Mandrekar as Alliance Group Statistician, is responsible for all statistics, data management, and information technology (IT) functions for the Alliance and, as such, is an integral part of the Alliance’s mission. All SDMC activities are primarily consolidated at the Mayo Clinic, supported by a diverse, experienced, and effective leadership and operational team. The central focus of the SDMC is on streamlining, and standardization, which is achieved through the implementation of Rave for data collection and supported by a single information systems infrastructure. All Alliance SDMC systems are set up to be flexible, adaptable, robust, and scalable. The SDMC is a recognized leader and contributor in the NCTN program including active participation in the NCI steering committees and task forces, NCI streamlining clinical trials efforts, the Clinical Trials Innovation Unit and in the assessment and implementation of the NCTN tools and systems. The SDMC has pioneered new data standards within electronic health records through initiatives such as the minimal common oncology data elements, mCODE, and Integrating Clinical Trials and Real-World Endpoints, iCARE. These will help achieve interoperability and enable progress in clinical care quality initiatives, clinical research, and healthcare policy development. A key strength of the Alliance is the ability to harness data collected across trials to improve aspects of trial design and conduct and more fully understand factors that drive outcomes. The SDMC is a leader in data sharing, promoting the widest possible sharing of Alliance data with the clinical research community while keeping protected health data safe and secure. Alliance faculty include methodological leaders in clinical trial designs including biomarker-driven trial designs, SMART, pragmatic and adaptive design strategies, surrogate endpoint evaluations, development of methodology and computing tools for high dimensional data, and patient reported outcomes. The SDMC is uniquely positioned to help with the rapid integration of biomarkers, mechanistic models, and other systems biology approaches into clinical trials. The Alliance SDMC is perfectly poised to meet the challenges of cancer clinical trials in 2026 and beyond.