CF 2: Biostatistics and Bioinformatics Core

核心2：生物统计学和生物信息学 摘要 生物统计学和生物信息学核心将支持软组织肉瘤孢子的研究人员， 他们的研究工作的计算和统计方面，包括设计和分析 实验室实验、分子谱分析和临床试验。在实验室实验中， 委员会成员将协助制定实验设计和分析解释 研究结束时的数据。核心还将协助大规模的分子 表征细胞系和人肿瘤样品以鉴定肿瘤特征的预测因子， 药物反应和存活率。在临床试验设计阶段，一名核心成员将进行方案 与主要研究者进行审查;根据该审查，将对方案的统计部分进行 提供了，概述了主要科学目标，研究人口，小学和中学 终点、实验设计、分析计划和目标样本量的概率合理性 术语;在试验结束时，将进行数据分析，以评估主要 和方案中规定的次要终点。核心将进行统计和生物信息学 使用适当的最先进的方法进行分析，并将开发替代方法， 目前的方法不足以解决一个研究问题。此外，核心将促进 管理和更新临床肉瘤数据库的领导人合作， 研究项目和软组织肉瘤孢子的其他三个核心。

Core 2: Biostatistics and Bioinformatics ABSTRACT The Biostatistics & Bioinformatics Core will support investigators of the Soft Tissue Sarcoma SPORE in the computational and statistical aspects of their research efforts, including the design and analysis of laboratory experiments, molecular profiling assays, and clinical trials. In laboratory experiments, core members will assist in the formulation of the experimental design and in the analysis and interpretation of the data at the conclusion of the study. The core will also assist in the large-scale molecular characterization of cell line and human tumor samples to identify predictors of tumor characteristics, drug response, and survival. In the clinical trial design phase, a core member will conduct a protocol review with the principal investigator; 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 analyses will be performed to assess outcomes of the primary and secondary endpoints stated in the protocol. The core 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. 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 Soft Tissue Sarcoma SPORE.