Biostatistics and Bioinformatics Shared Resource Facility

项目总结/摘要 生物统计学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，并通过提供统计和 生物信息学专业知识，使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）研究计划、把握度和样本量 资助申请的计算; 2）临床试验的设计和实施支持; 3）统计 分析，包括整个癌症研究范围的中期和最终分析; 4） 用于设计和分析高通量组学数据的生物信息学方法; 5） 数据质量控制和数据处理;以及6）对MCC进行指导、教育和一般咨询 investigators. BB SRF服务通过交接和综合工作流程与其他MCC SRF协调 确保提供全面、无缝和不重叠的支助。在当前的供资周期内，BB 战略成果框架通过采用直接支持千年挑战委员会的技术方法， 研究计划主题。这些技术方法包括制定和实施国家- 最先进的数据处理和数据分析管道和软件，用于具有特定功能的多个基因组平台 应用于肯塔基州的阿巴拉契亚人口;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外泌体数据;自适应和基于模型的剂量 发现设计和最先进的设计，用于早期试验，包括生物标志物和基因组评价， 靶向治疗;基于人群的癌症预防研究的统计方法，包括 风险因子分布的非参数估计和假设检验，相对生存估计， 癌症登记处和大型索赔数据库的统计方法，以支持MCC的研究， 健康差距。除了作为共同调查员在52项新供资的赠款和40多名调查员中提供支助外， 启动试验，BB SRF教师从事新的方法学工作，以提高MCC的科学 研究计划。在当前的CCSG供资周期内，BB SRF支持了128个管理协委会成员（81 来自所有4个MCC研究计划的同行评审资助），占MCC总覆盖率的74% 会员资格 BB SRF显著提高了使用率和增值指标，扩展了服务， 为了应对增长和新兴的问题，教职员工人数从8名增加到目前的14名 MCC的研究方向。BB SRF经验丰富的人员和多样化的技能组合增加了 对MCC进行科学严谨的研究具有重大价值，并表明BB SRF有能力支持MCC成为英联邦的综合癌症中心。 肯塔基州在此更新申请。

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.