Core 3: Biostatistics Core

核心3 -总结 核心3将与P01研究者就研究设计和数据分析进行合作和咨询，以确保 转化和机械研究将满足统计严谨性的高科学标准。请求的 资金将为项目1-3中提出的人体研究和细胞系实验提供统计支持， 包括与Core 1在数据管理和计算组件方面的合作。特别是 生物统计学核心是一个专门的设施，提供现成的和专门的访问： 目标1：人体研究和细胞系实验的设计，规划和实施的统计专业知识。 样本量的考虑在辐射方式与剂量测定，成像， 循环和组织生物标志物。 目标2：人体研究和细胞系数据分析、解释和报告的统计专业知识 实验分析计划包括（a）风险预测模型的开发和验证（B） 添加基于模型性能的生物标志物（c）中介建模以分解因果关系 辐射诱导的淋巴细胞减少症或DNA损伤反应对患者结局的直接和间接影响。 目标3：就（a）表格设计，包括编码惯例和变量，与核心1进行数据库咨询 格式（B）数据库规格，包括输出数据集的格式（c）质量控制和审计 流程.

CORE 3 - SUMMARY Core 3 will collaborate and consult with P01 Investigators on study design and data analysis to ensure the translational and mechanistic research will satisfy high scientific standards for statistical rigor. The requested funding will provide statistical support to the human studies and cell line experiments proposed in Projects 1-3, including collaboration with Core 1 on data management and computational components. In particular, the Biostatistics Core is a dedicated facility to provide ready and specialized access to: Aim 1: Statistical expertise for the design, planning and conduct of human studies and cell line experiments. Sample size considerations are critical in comparative studies of radiation modalities with dosimetry, imaging, circulating and tissue biomarkers. Aim 2: Statistical expertise for data analysis, interpretation and reporting of human studies and cell line experiments. Analysis plans include (a) development and validation of risk prediction models (b) assessment of adding a biomarker based on model performance (c) mediation modeling to decompose causal relationships into direct and indirect effects of radiation-induced lymphopenia or DNA damage response on patient outcome. Aim 3: Database consultation with Core 1 on (a) forms design, including coding conventions and variable formats (b) database specifications, including formatting of output datasets (c) quality control and audit processes.