Core C: Immune bioinformatics and biostatistics

摘要 免疫生物信息学和生物统计学(核心C)将提供关键的基础设施和共享资源 生物统计和生物信息学专业知识，用于设计、实施和分析 P01--“癌症免疫治疗的放射和检查站封锁”。Core C将提供以下服务 在研究的每个阶段都有P01项目。核心成员将：1)就研究的选择与调查人员进行磋商 设计；2)开发关系数据库来存储临床试验患者的相关数据以供分析；3)生成 来自肿瘤、外体、PMBC(T细胞)和肿瘤的基于DNA和RNA的大规模并行测序数据 渗透淋巴细胞；4)利用生物信息学和 生物统计学；5)使用多个临床前和临床前分析执行更高级别的二级和综合分析 数据类型；6)创建图表，协助调查人员编写进度报告； 演示文稿和手稿；7)就后续研究的设计进行咨询；8)负责 在基因组数据共享方面实施共享资源计划。这些目标将是 通过以下具体目标实施--目标1)在设计和开发方面提供生物统计学专门知识 对拟议项目的分析；目标2)为DNA的产生和初步分析提供支持- 和基于RNA的大规模并行测序数据；以及目标3)进行二次和综合 跨平台和数据类型的分析。P01的一个主要主题是研究检查站的影响 通过临床试验对人体进行封锁和放射治疗，并同时进行相关的临床前研究 在老鼠身上进行的研究。核心C成员将在促进两组之间的比较方面发挥至关重要的作用，因为 他们将参与对人类和老鼠样本的相同分析，提供一条知识渠道 在项目之间。核心成员在临床试验、生物统计学、数据库设计方面拥有丰富的经验 并实现了大规模并行测序、生物信息学分析和利用 用于整合项目产生的多种数据类型的分析技术。免疫者 生物信息学和生物统计学核心将作为P01的基本资源，提供专门的 专业知识，使调查人员能够以稳健和高效的方式完成他们的研究。核心成员 C将以协同和合作的方式与项目调查人员合作，以确定安全性、有效性 和局部放射治疗与免疫关卡封闭相结合的作用机制 了解临床前和临床样本的免疫学和遗传学特征 反应、抵抗和复发。

SUMMARY The Immune Bioinformatics and Biostatistics (Core C) will provide critical infrastructure and shared resources of biostatistic and bioinformatic expertise for the design, conduct and analyses of the Research Projects within the P01 - “Radiation and Checkpoint Blockade for Cancer Immune Therapy.” Core C will provide services to P01 projects at every stage of research. Core members will: 1) consult with investigators on selection of study designs; 2) develop a relational database to store clinical trial patient correlative data for analysis; 3) generate DNA and RNA-based massively parallel sequencing data from tumors, exosomes, PMBCs (T cells), and tumor infiltrating lymphocytes; 4) conduct efficient and robust data analyses, utilizing both bioinformatics and biostatistics; 5) perform higher level secondary and integrative analyses using multiple pre-clinical and clinical data types; 6) create graphs and tables, assist investigators with the preparation of progress reports, presentations and manuscripts; 7) consult on the design of subsequent research; and 8) be responsible for the implementation of the Shared Resources Plan in regards to Genomic Data Sharing. These goals will be implemented through the following specific aims – Aim 1) To provide biostatistical expertise in design and analysis for the proposed projects; Aim 2) To provide support for the generation and initial analysis of DNA- and RNA-based massively parallel sequencing data; and Aim 3) To perform secondary and integrative analyses across platforms and data types. A major theme of the P01 is studying the effect of checkpoint blockade and radiation therapy in humans through clinical trials, and concurrently performing linked pre-clinical studies in mice. Core C members will play a vital role in facilitating the comparison between the two groups, as they will be involved in the same analyses on human and mouse samples providing a conduit of knowledge between Projects. Core members have extensive experience in clinical trials biostatistics, database design and implementation, performance of massively parallel sequencing, bioinformatics analysis, and the utilization of analytical techniques for integration of the multiple data types generated from the Projects. The Immune Bioinformatics and Biostatistics Core will serve as an essential resource for the P01, providing specialized expertise to allow investigators to complete their research in a robust and efficient fashion. Members of Core C will work in a synergistic and cooperative fashion with Project investigators to determine the safety, efficacy and mechanism of the combination of local radiation therapy and immune checkpoint blockade and to understand the immunologic and genetic features of pre-clinical and clinical samples that are determinants of response, resistance, and relapse.