Biostatistics Shared Resource

生物统计和生物信息学共享资源(BBSR)的主要目标是促进同行评议 维克森林浸信会综合癌症中心(WFBCCC)成员研究。BBSR 在癌症相关研究的所有阶段与所有四个科学项目的成员合作 项目。主要负责方法论、统计学、生物信息学和计算 问题，包括研究设计、抽样、临床试验监测的统计方面、中期审查和最终结果 分析。BBSR支持以下五个领域：1)临床方案开发，包括开发 制定适当的统计设计，编制统计章节，审查所有 提交WFBCCC审查的方案；2)临床方案监测和分析，包括 监控患者收益，为质量保证工作提供支持，并执行临时(当 所需)和最终分析；3)统计设计和数据分析，以支持赠款发展和 出版物，包括与来自所有项目的WFBCCC调查人员合作，提供指导 并在研究研究和赠款的所有阶段提供支持。这方面的服务包括会见 WFBCCC调查人员讨论潜在赠款的设计和分析计划，定期进行 与WFBCCC调查人员计划关于潜在赠款的会议，执行数据统计分析 并提供对结果的解释，作为演示、摘要和出版物的一部分；4)信息学 从所有项目向WFBCCC调查人员提供服务，包括基因组数据处理、生物信息学 分析、数据注释和可视化/共享，以支持基础、翻译和临床癌症研究 通过利用机构维护的翻译数据仓库；以及5)领导力、教育和 培训，包括参加研究生级别的课程、T32培训补助金、K 获奖者和其他年轻研究人员，负责科学和技术研究的委员会的成员/领导层 为WFBCCC作出行政决定，并协调每月一系列的研讨会和短期课程 WFBCCC成员的统计和/或生物信息学方法。 BBSR由小拉尔夫·达戈斯蒂诺博士和周晓波博士共同执导，是一部利用率很高的 为WFBCCC提供经济高效的资源。从2014年11月1日到2015年10月31日，BBSR 为癌症相关工作提供了超过5,000小时的支持，并协助了105名调查人员(90名WFBCCC 会员)，同时从所有四个WFBCCC计划获得约1.9 FTE的财务支持 癌症中心支持赠款(由WFBCCC机构资金提供的额外支持)。在……里面 此外，在本报告年度，BBSR向23名新开设的调查员提供了统计支助 启动方案，为20个临床方案审计提供支持，审查120多个方案以进行统计 内容，监测了200多个开放协议，在2015年协助了39篇已发表的手稿(总共超过185篇 在赠款期间)，协助提交了20多份校外赠款申请，目前合作了22多份 为癌症相关赠款提供资金，2014年的综合直接成本约为810万美元。

The primary goal of the Biostatistics and Bioinformatics Shared Resource (BBSR) is to facilitate the peer-reviewed research of Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) members. The BBSR collaborates with members from all four scientific Programs throughout all phases of cancer-related research projects. Major responsibilities are assumed for methodological, statistical, bioinformatics, and computational issues, including study design, sampling, statistical aspects of clinical trial monitoring, interim reviews, and final analysis. The BBSR supports the following five areas: 1) Clinical Protocol Development, including development of appropriate statistical designs, preparing statistical sections, and reviewing the statistical content of all protocols submitted for review at the WFBCCC; 2) Clinical Protocol Monitoring and Analyses, including monitoring patient accrual, providing support for quality assurance efforts, and performing interim (when needed) and final analyses; 3) Statistical Design and Data Analysis in Support of Grant Development and Publications, which includes collaborations with WFBCCC investigators from all Programs to provide guidance and support in all stages of research studies and grants. This aspect of service involves meeting with WFBCCC investigators to discuss the design and analysis plans for potential grants, conducting regular planning sessions with WFBCCC investigators about potential grants, performing statistical analyses of data and providing interpretations of results as parts of presentations, abstracts, and publications; 4) Informatics Services to WFBCCC investigators from all Programs, including genomics data processing, bioinformatics analyses, data annotation and visualization/sharing to support basic, translational and clinical cancer research by leveraging the institutionally-maintained Translational Data Warehouse; and 5) Leadership, Education, and Training, including participation in graduate-level courses, T32 training grants, mentoring teams for K awardees and other young investigators, membership/leadership on committees responsible for scientific and administrative decisions for the WFBCCC, and coordination of a monthly seminar series and short courses on statistical and/or bioinformatics methods for WFBCCC members. The BBSR is co-directed by Ralph D’Agostino, Jr., Ph.D., and Xiaobo Zhou, Ph.D., and is a highly utilized and cost-efficient Resource for the WFBCCC. From November 1, 2014 through October 31, 2015, the BBSR provided over 5,000 hours of support for cancer-related work and assisted 105 investigators (90 WFBCCC Members) from all four WFBCCC Programs while receiving approximately 1.9 FTEs of financial support from the Cancer Center Support Grant (with additional support provided by WFBCCC institutional dollars). In addition, during the reporting year the BBSR provided statistical support to 23 newly-opened investigator initiated protocols, provided support for 20 clinical protocol audits, reviewed over 120 protocols for statistical content, monitored over 200 open protocols, assisted in 39 published manuscripts in 2015 (over 185 total during grant period), assisted on 20+ extramural grant submissions, and collaborated on over 22 currently funded cancer-related grants with combined direct costs for 2014 of approximately $8.1 million.