Bioinformatics and Biostatistics Core

项目摘要 生物统计学和生物信息学核心（核心C）的目标是解决统计设计和分析 耶鲁大学头颈癌孢子项目（YHN-SPORE）的需求，核心，发展 研究计划（DRP）和职业发展计划（CDP）。为了实现这一目标，我们 组建了一个高度互动的癌症生物统计学家和生物信息学家团队， 与基础，临床，转化和人口科学研究人员合作，以推进 癌症药物生物统计学和生物信息学核心的具体目标是： 目标1：在设计、执行、监测和分析基础、 YHN-SPORE的翻译、人群和临床研究。 目标2：监督和协调数据的收集、管理和分析。确保收集的数据 所有YHN-SPORE研究都是高质量的，经过生物信息学和统计学严格评估， 在SPORE附属的协作组中可访问，最终实现最广泛的可访问性， 考虑到出版和隐私问题，这是适当的。 对于目标1，核心将与研究人员密切合作，分析临床试验和临床前数据， 代测序数据和生物信息学数据挖掘。核心小组提供的服务将包括 从规划和设计活动到具体分析问题的咨询。核心将解决分析 以及YHN-SPORE项目中出现的信息学问题。核心将严格设计和监控 安全性、有效性和无效性的临床试验。核心将安排与YHN-SPORE的定期会议 研究人员，并保持对任何生物统计学和生物信息学问题的开放政策。核心 将进行中期和最后分析，根据需要制定新的统计和生物信息学方法， 及时为YHN-SPORE研究者提供建议，在整个研究中发挥重要作用。 生物统计学和生物信息学也是YHN-SPORE的重要合作伙伴，其高级代表 领导团队并参与所有核心会议。对于目标2，核心将与耶鲁癌症合作 中心（YCC），耶鲁大学分析科学中心（YCAS），福克斯大通癌症中心（FCCC）及其 量化核心，以促进YHN-SPORE研究人员之间的沟通，创建和实施 用于收集、存储和访问各种类型的数据（例如，实验室， 临床、人口和基因组数据）。核心是高度 与项目相结合，并将定期与项目调查人员以及YCAS数据举行会议 管理人员，以评估研究产生的数据，并确保准确和最新的数据 管理 ​​ ​​

Project Summary The goal of the Biostatistics and Bioinformatics Core (Core C) is to address the statistical design and analysis needs of the Yale SPORE in Head and Neck Cancer (YHN-SPORE) Projects, the Cores, the Developmental Research Program (DRP), and the Career Development Program (CDP). To accomplish this goal we have assembled a highly interactive team of cancer biostatisticians and bioinformaticians who will work collaboratively with basic, clinical, translational, and population science researchers to advance the frontiers of cancer medicine. The specific aims of the Biostatistics and Bioinformatics Core are: Aim 1​: ​Provide collaboration and consulting in the design, execution, monitoring and analysis of basic, translational, population, and clinical studies for YHN-SPORE. Aim 2​: ​Oversee and coordinate the collection, management, and analysis of data. Ensure that data collected on all YHN-SPORE studies are of high quality, are evaluated with bioinformatic and statistical rigor, are accessible within SPORE-affiliated collaborative groups, ultimately enabling the widest accessibility that is appropriate given publication and privacy concerns. For Aim 1, the Core will work closely with the investigators to analyze clinical trial and pre-clinical data, next generation sequencing data, and bioinformatics data mining. Services provided by the Core will range from planning and design activities to consulting on specific analytic questions. The Core will address the analytic and informatics questions arising from the YHN-SPORE projects. The Core will rigorously design and monitor clinical trials for safety, efficacy and futility. The Core will schedule regular meetings with the YHN-SPORE investigators, and maintain an open-door policy for any biostatistical and bioinformatics questions. The Core will conduct interim and final analyses, develop new statistical and bioinformatics methodology as needed, provide timely suggestions to YHN-SPORE investigators, and thus play an important role in the entire study. Biostatistics and Bioinformatics is also a key partner in the YHN-SPORE with representation on their Senior Leadership Team and participation in all core meetings. For Aim 2, The Core will work with the Yale Cancer Center (YCC), Yale Center for Analytical Sciences (YCAS), Fox Chase Cancer Center (FCCC) and its quantitative cores to facilitate communication among YHN-SPORE researchers, creating and implementing web-accessible databases for collecting, storing and accessing the various types of data (e.g. laboratory, clinical, population, and genomic data) that will be generated for the YHN-SPORE projects. The Core is highly integrated with the projects, and will have regular meetings with project investigators, as well as YCAS data managers, to evaluate the data generated from the studies and ensure accurate and up-to-date data management. ​​ ​​