Shared Resource 03: Biostatistics (BSR)

项目摘要--生物统计共享资源(BSR) BSR在生物统计和设计方面提供了集中的专业知识资源 临床/转化性、基础和基于人群的癌症研究。BSR的具体目标是：1) 在定量翻译研究的各个方面与OSUCCC调查人员合作，包括研究 设计、培训和教育、可重复性和科学严谨性、统计分析、数据可视化和 手稿和报告准备；2)通过提供生物统计学的 所有OSUCCC研究计划和疾病特定研究小组(DSRGs)的“导航员”，以及 向OSUCCC成员提供教育和生物统计培训；以及3)提供生物统计和 向OSUCCC临床科学审查委员会提交的所有癌症方案的方法学审查 (中国证监会)和数据安全监测委员会(DSMC)，并根据全面癌症护理(TCC)的需要 BSSR研究委员会。为了支持癌症研究中的团队科学，BSR建立了一个导航器- 2013年的系统，现在在当前周期扩大到俄亥俄州立大学和全国儿童基金会的20个不同的小组 医院(NCH)，生物统计学家嵌入每个DSRG并参与所有研究 从他们一开始就学习。导航员对临床、生物学和统计学问题非常熟悉 他们支持并充当在这些群体和更广泛的群体之间建立合作的关键人物 俄亥俄州立大学社区。所有五个OSUCCC计划都规定了办公时间，在那里，导航员 生物统计学家每隔一周在规定的空间里呆上半天。BSR还积极举办了研讨会， 研讨会和课程，致力于培训生物医学研究人员设计、分析和 科学的严谨性。在当前周期中，BSR使用来自TCC的基因组数据支持个人研究人员 协议、俄亥俄州立大学的肿瘤学研究信息交换网络(Orien)阿凡达计划，以及 全国以患者为中心的研究临床网络(PATH)，提供计算和编程 支持、数据可视化、图形和查询工具以及数据解释。BSR与其他 共享资源和DSMC和中国证监会在协议的开发和实施中确保 HIPAA合规流程，通过实施可查找、可访问 可互操作和可重复使用的(公平)指南。在本周期内，BSR支持了405份出版物 (59&>10个影响因素)和98个NIH(53个NCI)补助金，包括26个R01，35个R21，1个R03，14个U01，5个U24，3 U19，3 U54，8 P01，2 P30，1 P50。在下一个赠款周期中，BSR在新的战略优先事项中的作用 OSUCCC，包括免疫肿瘤学、翻译基因组学、癌症工程学和癌症预防 和幸存将大幅增加BSR的贡献，并将具体包括新招募的人员和 技术。BSR的年度预算是4,063,515美元，而CCSG的请求是231,260美元。因此， BSR利用广泛的机构支持，仅从CCSG基金寻求5.7%的支持。

PROJECT SUMMARY – BIOSTATISTICS SHARED RESOURCE (BSR) The BSR provides a centralized resource of expertise in the biostatistical and design aspects of clinical/translational, basic, and population-based cancer research. The specific aims of the BSR are to: 1) collaborate with OSUCCC investigators in all aspects of quantitative translational research including study design, training and education, reproducibility and scientific rigor, statistical analysis, data visualization, and manuscript and report preparation; 2) enable strong and consistent collaborations by providing a biostatistical “navigator” to all OSUCCC research programs and Disease Specific Research Groups (DSRGs), and by providing education and biostatistical training to OSUCCC members; and 3) provide biostatistical and methodological review of all cancer protocols submitted to the OSUCCC Clinical Scientific Review Committee (CSRC) and Data Safety Monitoring Committee (DSMC), and as needed for the Total Cancer Care (TCC) research committee for the BSSR. To bolster team science in cancer research, BSR established a navigator- system in 2013, now expanded over the current cycle to 20 different groups at OSU and Nationwide Children's Hospital (NCH), whereby biostatisticians are embedded within each DSRG and are involved with all research studies from their inception. Navigators are intimately familiar with the clinical, biological, and statistical issues they support and serve as point persons for establishing collaborations between these groups and the broader OSU community. Office hours were established within all five OSUCCC programs, where the navigator biostatistician spends half a day every other week at a provided space. BSR also actively developed workshops, seminars, and courses devoted to training biomedical investigators in the fundamentals of design, analysis, and scientific rigor. Over the current cycle, BSR supported individual investigators using genomic data from the TCC protocol, the Oncology Research Information Exchange Network (ORIEN) Avatar program at OSU, and the National Patient-Centered Research Clinical Network (PaTH) by providing computational and programming support, data visualization, graphical and query tools, and data interpretation. BSR works together with other shared resources and the DSMC and CSRC in the development and implementation of protocols to ensure HIPAA compliant processes, and high data quality by enforcing the application of Findable, Accessible, Interoperable, and Reusable (FAIR) guidelines. During the current cycle, the BSR supported 405 publications (59 > 10 impact factor) and 98 NIH (53 NCI) grants including 26 R01s, 35 R21s, 1 R03, 14 U01s, 5 U24s, 3 U19s, 3 U54s, 8 P01s, 2 P30s, 1 P50. Over the next grant cycle, the BSR's role in the new strategic priorities for the OSUCCC, including immuno-oncology, translational genomics, cancer engineering and cancer prevention and survivorship will substantially increase the BSR's contributions, and will specifically include new recruits and technologies. The annual budget of the BSR is $4,063,515, yet the CCSG request is $231,260. As such, the BSR leverages extensive institutional support and seeks only 5.7% support from CCSG funds.