Core B: Biostatistics Core

项目总结/摘要 生物统计学核心的作用是支持前列腺癌中SPORE的研究人员， 他们的研究工作，包括实验室实验和临床试验的设计和分析， 审判对于临床前研究，核心成员将协助制定实验性 设计以及在研究结束时分析和解释数据。核心 在临床试验期间，成员将与主要研究者一起进行方案审查 设计阶段。基于该审查，我们将提供方案的统计部分， 概述主要科学目的、研究人群、主要和次要终点， 实验设计，必要时的随机化程序，分析计划和有针对性的 样本量在概率方面合理。在试验结束时，将进行数据分析， 用于评估方案中规定的主要和次要终点的结局。 如果目前的统计方法不能充分解决这方面的研究问题， SPORE，将探索替代方法。统计研究的例子 与纪念斯隆-凯特琳癌症中心的临床和实验室研究人员合作， 中心包括以下领域：临床和临床前试验设计，以及数据分析。 生物统计核心的具体目标是： 目标1.为基于实验室的前列腺癌研究的设计和分析做出贡献; 目标2.参与前列腺癌临床研究的设计和分析; 目标3。发展有助于前列腺癌进展的统计方法 research.

PROJECT SUMMARY/ABSTRACT The role of the Biostatistics Core is to support investigators of the SPORE in Prostate Cancer in their research efforts, including laboratory experiments and the design and analysis of clinical trials. For preclinical studies, 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 studies. A core member will conduct a protocol review with the principal investigator during the clinical trial design phase. Based on this review, we will provide a statistical section for the protocol, outlining major scientific objectives, population to be studied, primary and secondary endpoints, experimental design, a randomization procedure if necessary, 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. If current statistical methodology does not adequately address a research question in this SPORE, alternative methodologies will be explored. Examples of statistical research spawned from collaborations with clinical and laboratory researchers at Memorial Sloan Kettering Cancer Center include the following areas: clinical and preclinical trial design, and data analysis. The specific aims of the Biostatistics Core are to: Aim 1. Contribute to the design and analysis of laboratory-based prostate cancer research; Aim 2. Contribute to the design and analysis of clinical studies in prostate cancer; Aim 3. Develop statistical methodology that will assist in the advancement of prostate cancer research.