Biostatistics Core

项目摘要/摘要——生物统计学核心 生物统计学核心的作用是支持纪念斯隆凯特琳癌症中心的研究人员 胰腺 SPORE 在其研究工作的计算和统计方面，包括设计和 实验室实验、临床试验、分子谱研究和成像研究的分析。在此之前 所有研究开始后，核心人员将与 SPORE 研究人员协商，讨论潜在的科学依据 项目的前提和转化目标，帮助研究人员选择最有效和最稳健的 分析方法，并估计样本量，以确保有足够的能力来实现研究目标。在 实验室实验，核心成员将协助制定实验设计和 在研究结束时对数据进行分析和解释。对于临床研究，核心成员将工作 与 SPORE 研究人员一起概述主要科学目标；要研究的人群；初级， 次要和探索性终点；实验设计；分析计划；以及合理的目标样本量 从概率的角度来说。试验结束时，将进行数据分析以评估结果 研究。对于使用人体组织的分子研究，核心成员将与团队密切合作 成员进行生物信息学分析，并将主要负责合并分子和 临床数据，以及进行适当的统计和生物信息学分析。的成员 Biostatistics Core 还将与 SPORE 研究人员合作，格式化数据以供发布。对于影像学研究， 核心成员将评估不同成像方式定位胰腺癌的能力。影像学 研究和放射组学分析也将用于确定治疗反应的潜在生物标志物。 随着研究的进行，核心人员将建议对设计和分析计划进行修改，如下所示 适当的。他们还将协助调查人员准备任何必要的图表、 对结果的解释、演示文稿和手稿的准备，并将就设计进行咨询 后续研究。如果当前的统计方法不能充分解决研究问题， 将开发替代方法。经验丰富且协作的生物统计核心非常出色 旨在为 SPORE 提供高水平的统计领导和支持，从而增强 其科学的效率、质量和定量严谨性。

PROJECT SUMMARY/ABSTRACT – BIOSTATISTICS CORE The role of the Biostatistics Core is to support the investigators of the Memorial Sloan Kettering Cancer Center Pancreas SPORE in the computational and statistical aspects of their research efforts, including the design and analysis of laboratory experiments, clinical trials, molecular profiling studies, and imaging studies. Prior to the initiation of all studies, Core staff 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 the formulation of the experimental design and in the analysis and interpretation of the data at the conclusion of the study. For clinical studies, Core members will work with SPORE investigators to outline the major scientific objectives; the population to be studied; primary, secondary, and exploratory 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 the outcomes of the study. For molecular studies using human tissues, Core members will closely interface with the team members performing bioinformatics analysis and will have primary responsibility for merging molecular and clinical data, and for performing appropriate statistical and bioinformatics analyses. The members of the Biostatistics Core will also work with SPORE investigators to format data for publication. For imaging studies, Core members will assess the ability of different imaging modalities to localize pancreatic cancer. Imaging studies and radiomics analysis will also be employed to identify potential biomarkers of response to treatment. As the research studies proceed, Core staff will suggest modifications to the design and analysis plans as appropriate. They will also assist investigators with the preparation of any necessary graphs and tables, the interpretation of results, the preparation of presentations and manuscripts, and will consult on the design of subsequent research. If current statistical methodology does not adequately address a research question, alternative methodologies will be developed. The experienced and collaborative Biostatistics Core is well configured to provide the SPORE with a high level of statistical leadership and support that will enhance the efficiency, quality, and quantitative rigor of its science.