Biostatistics and Bioinformatics Shared Resource Facility

项目摘要/摘要 生物统计和生物信息学共享资源设施(BB SRF)是一个重要的癌症中心- 管理资源，并作为团队成员在团队科学中发挥关键作用，提供统计和 生物信息学专业知识，以支持和加强马基癌症中心(MCC)的基础、临床和 人口研究。BB SRF服务大致分为：1)研究规划、力量和样本量 赠款申请的计算；2)临床试验的设计和实施支持；3)统计 分析，包括对整个癌症研究研究的中期和最终分析；4) 设计和分析高通量组学数据的生物信息学方法；5)统计编程 数据质量控制和数据处理；6)向MCC提供指导、教育和一般咨询 调查人员。BB SRF服务与其他MCC SRF通过移交和集成工作流进行协调 确保全面、无缝和不重叠的支持。在本供资周期内，BB SRF通过采用直接支持MCC的技术方法产生了重大的科学影响 研究计划主题。这些技术方法论包括开发和实施国家 用于多个基因组平台的最先进的数据处理和数据分析管道和软件 应用于肯塔基州阿巴拉契亚地区的人口；新的差异分析和分类方法 用于肺癌、乳腺癌和胰腺癌的代谢组学和胞外体数据；适应性和基于模型的剂量 利用生物标记物和基因组学评估为早期试验寻找设计和最先进的设计 靶向治疗；基于人群的癌症预防研究的统计方法，包括 风险因素分布的非参数估计和假设检验、相对生存估计和 癌症登记和大型索赔数据库的统计方法，以支持MCC在#年的研究 健康差距。除了在52项新资助的赠款和40多名调查人员中作为联合调查人员提供支持外- 发起试验，BB SRF教职员工从事新的方法学工作，以加强MCC的科学 研究项目。在当前的CCSG供资周期内，BB SRF支持了128个MCC成员(81 同行评审资助)来自所有4个MCC研究计划，占MCC总覆盖率的74% 会员制。 BB SRF显著增加了使用率和增值指标，扩展了其服务，并 人员从8名教职员工增加到目前的14名，以应对增长和新出现的 MCC的研究方向。BB SRF的高度经验丰富的人员和多样化的技能集增加了 对在MCC进行科学严谨的研究具有重要价值，并表明BB SRF处于有利地位，支持MCC成为英联邦综合癌症中心 肯塔基州在这次续签申请中。

PROJECT SUMMARY/ABSTRACT The Biostatistics and Bioinformatics Shared Resource Facility (BB SRF) is an essential cancer center- managed resource and has played a critical role as members in team science by providing statistical and bioinformatics expertise to enable and enhance the Markey Cancer Center’s (MCC) basic, clinical and population research. BB SRF services are categorized broadly into: 1) study planning, power and sample size calculations for grant applications; 2) design and implementation support for clinical trials; 3) statistical analyses, including interim and final analysis for the entire spectrum of cancer research studies; 4) bioinformatics methods for design and analysis of high-throughput ’omics data; 5) statistical programming for data quality control and data processing; and 6) mentoring, education and general consultation to MCC investigators. BB SRF services are coordinated with other MCC SRFs with hand-offs and integrated workflows to ensure comprehensive, seamless and non-overlapping support. During the current funding cycle, the BB SRF has made significant scientific impact by employing technical methodologies directly supporting MCC Research Program themes. These technical methodologies include development and implementation of state- of-the-art data processing and data analysis pipelines and software for several genomic platforms with specific applications to Kentucky’s Appalachian population; novel differential analysis and classification methodologies for metabolomics and exosome data for lung, breast and pancreas cancers; adaptive and model-based dose finding designs and state-of-the art designs for early phase trials with biomarker and genomic evaluations of targeted therapies; statistical methodologies for population-based cancer prevention studies including nonparametric estimation and hypothesis testing of risk factor distributions, relative survival estimation and statistical methods for cancer registry and large claims databases to support research in MCC’s research in health disparities. In addition to support as co-investigators in 52 newly funded grants and over 40 investigator- initiated trials, BB SRF faculty engaged in novel methodological work to enhance the science of MCC Research Programs. During the current CCSG funding cycle, the BB SRF supported 128 MCC members (81 peer-reviewed funded) from all 4 MCC Research Programs, representing 74% coverage from the total MCC membership. The BB SRF has significantly increased usage and value added metrics, expanded its services and has grown in personnel from 8 faculty and staff to a current total of 14 to address the growth and emerging research directions of the MCC. The highly experienced personnel and diverse skill set of the BB SRF adds significant value to the execution of scientifically rigorous research at the MCC and demonstrates that the BB SRF is well positioned to support the MCC as a Comprehensive Cancer Center for the Commonwealth of Kentucky in this renewal application.