CF2: Biostatistics and Bioinformatics Core ABSTRACT The Biostatistics and Bioinformatics Core will support investigators of the SPORE in Soft Tissue Sarcoma in the computational and statistical aspects of their research efforts, including the design and analysis of laboratory experiments, molecular profiling assays, and clinical trials. Prior to the initiation of all studies, Core members will consult with SPORE investigators to discuss the underlying scientific premise and translational goals of the project, to help the investigators select the most efficient and robust analytical methods, and to estimate sample sizes to ensure adequate power to address study objectives. In laboratory experiments, Core members will assist in formulating the experimental design and in data analysis and interpretation at the conclusion of the study. For molecular profiling studies of cell line and human tumor samples, Core members will closely interface with the members of the Biospecimen and Pathology Core (CF1) for merging molecular and clinical data, perform appropriate statistical and bioinformatics analyses to identify biomarkers of drug response and survival outcome, and work with SPORE investigators to assist with deposition of genomic data into public repositories to facilitate research dissemination and study replication. When designing a clinical trial, a Core member will conduct a protocol review with the trial PI; based on this review, a statistical section for the protocol will be provided, outlining major scientific objectives, population to be studied, primary and secondary endpoints, experimental design, analysis plans, and a targeted sample size justified in probabilistic terms. At the conclusion of the trial, data will be analyzed to assess the primary and secondary endpoints stated in the protocol. CF2 will perform statistical and bioinformatic analyses using appropriate state-of-the-art methodologies and will develop alternative methods if current methodology does not adequately address a research question. CF2 will also assist investigators with the preparation of any necessary graphs and tables, formatting data for publication, and the preparation of presentations and manuscripts. In addition, the Core will facilitate the management and updating of the clinical sarcoma database in collaboration with the leaders of research projects and the other three cores of the SPORE in Soft Tissue Sarcoma. We believe that this experienced and collaborative Core is well configured to provide the SPORE in Soft Tissue Sarcoma with a high level of statistical and bioinformatics leadership and support that will enhance the efficiency, quality, and quantitative rigor of its science.