Biostatistics Shared Resource

生物统计学共享资源 导演：森本美博士 摘要/项目总结 骑士癌症研究所（骑士）生物统计共享资源（BSR）是一个癌症中心管理共享 我们的首要使命是通过生物统计学合作和咨询来影响癌症。 BSR的愿景是为基础，临床，人口， 科学和转化癌症研究人员在骑士。促进协作和团队科学，BSR 努力成为癌症研究团队的一个组成部分，并在整个生命周期中提供统计支持 从概念开发到出版的研究项目。除了提供支持， 个人研究人员，BSR提供统计咨询，以其他骑士支持共享资源， 并为多研究者、跨学科研究提供生物统计学专业知识和基础设施 项目BSR在支持癌症临床研究方面发挥着重要作用，包括试验设计、监测 和分析最后，BSR积极参与整个癌症研究的教育和培训 计划，通过研讨会和讲习班，期刊俱乐部，部门大轮，和研究具体 程序会议。 作为我们致力于最大限度地提高资源结构效率的一部分，骑士投资了 在BSR中提供大量资源，以建立专业知识和能力。这一承诺体现在 运营预算从2011财年（2010年7月至2011年6月）的267，015美元增加到2016财年（2010年7月至2011年6月）的1，394，432美元 2015年至2016年6月）。为了应对未来五年预期增长的大轨迹， 2014年9月受聘进行全面外部评价，评估用户满意度， 业务流程和程序以及人员配备。评估完成后，BSR制定了 五年增长和发展计划，以确保为现有研究者提供高质量的生物统计支持， 以及骑士招募的大量新调查员。此外，随着骑士继续 投资于新技术，包括高通量“组学”技术、成像、免疫监测和 基于细胞的技术，BSR需要先发制人地理解新技术产生的数据。 技术，支持预处理和数据管理工作流程，开发统计分析工作流程， 以及数据呈现和解释工具。骑士承诺继续提供大量的 执行工作队建议的资源，包括增加工作人员， 该股的业务活动;制定更健全的人员配置模式;制定网基 门户网站，可轻松与用户进行交互和沟通，提供项目管理工具，并跟踪人员配备和 使用指标;以及招聘更多的博士和硕士生物统计学家。额外目标 包括扩大第一阶段的设计专业知识;将生物统计工作人员纳入疾病特异性 研究团队改善与研究人员的早期合作;与计算生物学的协调 和集成基因组共享资源，为组学数据分析支持创建无缝管道。 2015年初，骑士扩大了与非营利组织癌症研究与生物统计学（CRAB）的合作。 位于华盛顿西雅图的实体。作为SWOG长期的统计和数据协调中心， CRAB是设计，管理和分析治疗和预防癌症临床试验的国家领导者。 与CRAB的合作大大提高了我们的能力和专业知识范围。这种关系 为Knight临床和翻译研究人员提供了直接访问经验丰富的高级癌症 生物统计学家的专业知识包括多中心临床试验，III期试验设计和早期检测试验。 BSR由癌症预防和控制成员Motomi（Tomi）Mori博士指导。BSR高度 被癌症研究人员使用，并始终表现出关键的科学贡献。在2011年至 2015年，BSR为来自所有四个研究项目的124名癌症研究人员提供了生物统计学支持。

BIOSTATISTICS SHARED RESOURCE Director: Motomi Mori, PhD ABSTRACT / PROJECT SUMMARY The Knight Cancer Institute (Knight) Biostatistics Shared Resource (BSR) is a cancer center managed shared resource with the overarching mission of impacting cancer through biostatistics collaboration and consulting. The BSR's vision is to provide comprehensive and integrated biostatistics support to basic, clinical, population science and translational cancer researchers at the Knight. Fostering collaboration and team-science, the BSR strives to be an integral part of cancer research teams and to provide statistical support throughout the life cycle of the research project from concept development through publication. In addition to providing support to individual researchers, the BSR provides statistical consultation to other Knight supported shared resources, and provides the biostatistics expertise and infrastructure to multi-investigator, transdisciplinary research projects. The BSR has a major role in supporting cancer clinical research, inclusive of trial design, monitoring and analysis. Finally, the BSR actively participates in education and training across the cancer research programs, through seminars and workshops, journal clubs, departmental grand rounds, and research-specific program meetings. As part of our commitment to maximize the effectiveness of the resources structure, the Knight has invested significant resources in the BSR to build expertise and capacity. This commitment is evidenced by the significant increase in operating budget from $267,015 in FY2011 (July 2010 - June 2011) to $1,394,432 in FY16 (July 2015 - June 2016). In response to large trajectory of expected growth over the next five years, a consultant was hired in September 2014 to conduct a comprehensive external evaluation that assessed user satisfaction, operational processes and procedures, and staffing. Following completion of the evaluation, the BSR developed a five-year growth and development plan to ensure high quality biostatistics support to existing investigators, as well as the large number of new investigators being recruited by the Knight. Additionally, as the Knight continues to invest in new technologies including high throughput `omics' technologies, imaging, immune monitoring and cell-based technologies, the BSR needs to be pre-emptive in understanding the data generated by the new technologies, support preprocessing and data management workflows, develop statistical analysis workflows, as well data presentation and interpretation tools. The Knight has committed to continue providing substantial resources to implement recommendations from the task force including the increased staffing to assist with business operations of the unit; development of a more robust staffing model; development of a web-based portal to easily interact and communicate with users, provide project management tools, and track staffing and usage metrics; and recruitment of additional PhD and masters level biostatisticians. Additional goals resulting from the plan include expanding phase I design expertise; integration of biostatistics staff into the disease specific research teams to improve early collaboration with investigators; and coordination with computational biology and the Integrated Genomic Shared Resource to create a seamless pipeline for omics data analysis support. In early 2015 the Knight expanded its collaboration with Cancer Research And Biostatistics (CRAB), a non-profit entity located in Seattle, Washington. As the long-standing statistical and data coordinating center for SWOG, CRAB is a national leader in designing, managing and analyzing therapeutic and preventive cancer clinical trials. The collaboration with CRAB has greatly enhanced our capacity and scope of expertise. The relationship has provided Knight clinical and translational researchers with immediate access to experienced, senior cancer biostatisticians with expertise including multi-site clinical trials, phase III trial designs, and early detection trials. The BSR is directed by Cancer Prevention and Control member Motomi (Tomi) Mori, PhD. The BSR is highly utilized by cancer researchers and consistently demonstrates key scientific contributions. Between 2011 and 2015, the BSR provided biostatistics support to 124 cancer researchers from all four research programs.