Project Summary/Abstract Overall Component The SWOG Statistics and Data Management Center (SDMC) provides leadership in the statistical design, data management, analysis, and reporting of NCTN clinical trials. It contributes to SWOG's overall mission to significantly improve lives through cancer clinical trials and translational research. The goals of the SDMC are to (a) rapidly design, develop, and implement rigorous and efficient multi-center clinical trials; (b) enhance systems for best monitoring of ongoing trials and ensure reproducibility of research using cross-study standardized software and systems for statistical analysis and clinical trials reporting; (c) develop innovative statistical design and software tools for incorporating integral and integrated biomarkers into clinical trials; (d) collaborate with other researchers on statistical methods research, including clinical trial design and the analysis of translational medicine studies, with a focus on precision medicine and challenges in the evaluation of immunotherapy; (e) investigate new strategies for enhancing NCTN data by constructing linkages to external databases and building a comprehensive repository of SWOG clinical and translational medicine data; and (f) advance the science of the NCTN program and the National Cancer Institute research agenda, in partnership with other NCTN investigators, by providing scientific leadership through participation in activities such as steering committees, working groups, task forces, data sharing, and clinical science meetings. The SWOG SDMC contributes to the goals of SWOG and partners with the NCTN to conduct trials within the current portfolio, while also providing data, strategies, and useful new statistical tools to other clinical trials organizations and oncology researchers.

Project Narrative Well-designed and well-conducted clinical trials are the primary means for evaluating new cancer therapies, advancing cures, reducing morbidity and mortality, and improving patient outcomes. The SWOG SDMC aims to be a leader in innovative trial design and analysis of science-driven publically funded Phase II and Phase III trials and translational medicine studies. Furthermore, our timely and high-quality trial implementation, management, and reporting ensure that the results of clinical trials have the greatest potential impact on cancer patients.