Biostatistics Core

项目摘要/摘要--生物统计核心 生物统计核心的作用是支持纪念斯隆·凯特琳癌症中心的调查人员 胰腺孢子在计算和统计方面的研究努力，包括设计和 实验室实验、临床试验、分子图谱研究和成像研究的分析。在此之前 启动所有研究，核心工作人员将咨询孢子调查人员，讨论潜在的科学 项目的前提和翻译目标，以帮助调查人员选择最高效和最健壮的 分析方法，并估计样本量，以确保有足够的能力来解决研究目标。在……里面 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 与孢子调查人员一起概述主要的科学目标；要研究的种群；主要的， 次级和探索性终点；实验设计；分析计划；有针对性的样本量 用概率的术语来说。在试验结束时，将进行数据分析，以评估 这项研究。对于使用人体组织的分子研究，核心成员将与团队密切联系 执行生物信息学分析的成员，将主要负责合并分子和 临床数据，并进行适当的统计和生物信息学分析。该委员会的成员 生物统计核心公司还将与孢子调查人员合作，格式化数据以供发布。对于成像研究， 核心成员将评估不同成像方式定位胰腺癌的能力。成象 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记物。 随着研究的进行，核心工作人员将建议修改设计和分析计划，如下所示 恰如其分。他们还将协助调查人员准备任何必要的图表， 解释结果，准备演示文稿和手稿，并将就设计 后续研究。如果目前的统计方法不能充分解决研究问题， 将开发替代方法。经验丰富和协作的生物统计核心很好 旨在为孢子提供高水平的统计领导和支持，以加强 其科学的效率、质量和定量的严谨性。

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.