Biostatistics Core

项目总结 在过去的几十年里，新的和强大的统计工具的发展以及越来越多的获取 低成本、高速计算对癌症研究产生了重大影响。因此，一个 统计学家在调查过程中合作的扩大和关键作用已经出现，以及更多 重要的是，在定义中建立了更高、更严格的标准，并被广泛接受 科学证据。值得注意的是，遗传学和基因组学通过大规模的分子生物学 有针对性的个性化医学方法在实验设计和数据方面提出了新的挑战 分析。例如，下一代测序和高密度基因分型产生了复杂的高密度 用于假设生成和推论测试的维度数据集。如此丰富的数据集构成了 由于大量的假设检验，研究设计、数据分析和结果解释方面的挑战， 基因途径效应和复杂的基因-基因相互作用。 生物统计核心将在研究设计和数据分析方面与孢子调查人员合作和咨询 建议的研究，以确保翻译研究将满足统计学的高科学标准 严谨。申请的资金将为细胞系和动物的临床前实验提供生物统计学支持。 项目1-3中的模型、用于相关分析的生物素研究、临床试验以及项目中的新研究 发展研究计划(DRP)和职业提升计划(CEP)。特别是， 生物统计核心是一个专门的设施，提供随时和专门的访问范围广泛的统计 专业知识和数据相关服务。 1.动物实验和人体研究的设计、规划和进行方面的统计专门知识。样本 在临床试验以及使用采集的血液和组织进行的生物量研究中，大小考虑是至关重要的 回溯性和前瞻性。前瞻性研究设计包括中期监测计划和早期停药 早期试验的规则。2.动物实验的数据分析和解释的统计专门知识 人体研究。人类受试者的数据分析计划包括识别和验证生物标志物 回顾研究和前瞻性研究。3.关于(A)表格设计的数据库咨询，包括变量 定义和编码惯例(B)数据库规格，包括可变格式和输出格式(C)质量 控制和审计流程。4.统计和数据库所需的计算设施和资源， 包括数据传输、合并、共享和安全。孢子项目可能需要转让和合并 来自不同数据库和实验室的临床、病理和分子数据，同时维护 个人识别码和受保护健康信息的机密性。

PROJECT SUMMARY During the last few decades, the development of novel and powerful statistical tools as well as increasing access to low-cost, high-speed computing have made significant impacts on cancer research. Consequently, an expanded and critical role has emerged for statisticians to collaborate in the investigative process, and more importantly, a higher and more rigorous standard has been established and accepted widely in the definition of scientific evidence. Notably, the rapid advances in genetics and genomics through large-scale molecularly targeted approaches to personalized medicine have presented new challenges in experimental design and data analysis. For example, next-generation sequencing and high-density genotyping generate complex high- dimensional datasets for hypothesis generation and inferential testing. Such rich datasets pose fundamental challenges in study design, data analysis, and results interpretation due to the large number of hypothesis tests, gene pathway effects, and complex gene-gene interactions. The Biostatistics Core will collaborate and consult with SPORE investigators on study design and data analysis of the proposed studies to ensure the translational research will satisfy high scientific standards for statistical rigor. The requested funding will provide biostatistical support to pre-clinical experiments in cell lines and animal models, biospecimen studies for correlative analysis, and clinical trials in Projects 1-3 as well as new studies in the Developmental Research Program (DRP) and Career Enhancement Program (CEP). In particular, the Biostatistics Core is a dedicated facility to provide ready and specialized access to a broad range of statistical expertise and data-related services. 1. Statistical expertise for the design, planning and conduct of animal experiments and human studies. Sample size considerations are critical in clinical trials as well as biospecimen studies using blood and tissue collected retrospectively and prospectively. Prospective study design includes interim monitoring plans and early stopping rules in early phase trials. 2. Statistical expertise for data analysis and interpretation of animal experiments and human studies. Data analysis plans for human subjects include the identification and validation of biomarkers in retrospective and prospective studies. 3. Database consultation on (a) forms design, including variable definitions and coding conventions (b) database specifications, including variable and output formats (c) quality control and audit processes. 4. Computing facilities and resources for statistical and database requirements, including data transfer, merging, sharing, and security. The SPORE projects may require transfer and merging of clinical, pathologic and molecular data from different databases and laboratories, while maintaining confidentiality of personal identifiers and protected health information.