Project Summary/Abstract Statistics Core The primary goals of the Statistics Core of the SWOG SDMC are to lead the design, development, and monitoring of rigorous clinical trials and translational medicine studies by using stringent, well-tested processes. Some specific aims of the Statistics Core faculty and staff are to (a) develop and rapidly implement scientifically sound and efficient clinical trials and collaborate on abstracts and manuscripts to ensure timely dissemination of results; (b) actively monitor ongoing trials using standardized processes and software; (c) conduct and collaborate on statistical methods research, including clinical trial design and the analysis of translational medicine studies; and (d) lead secondary analyses and cross-study research using the SWOG database. The SWOG SDMC Statistics Core approach is to use designs that lead to convincing conclusions, whether for Phase II, Phase III, or translational medicine objectives that guide new cancer treatment and science. As immunotherapy and targeted agents present challenges with respect to statistical evaluation, the Statistics Core faculty develop and evaluate the statistical properties of innovative and efficient designs to advance these new therapies.