Biostatistics Shared Resource

生物统计共享资源

• 批准号: 10205358
• 负责人: MOTOMI MORI
• 金额: $ 8.92万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10205358
• 关键词: Advisory Committees; Biological Markers; Biometry; Biostatistics Shared Resource; Budgets; Businesses; Cancer Center; Cancer Control; Cancer Research Project; Cells; Clinical; Clinical Research; Clinical Trials Design; Clinical effectiveness; Collaborations; Combined Modality Therapy; Communities; Complex; Computational Biology; Consult; Consultations; Creativeness; Data; Data Analyses; Data Collection; Data Coordinating Center; Development; Development Plans; Disease; Doctor of Philosophy; Early Diagnosis; Educational workshop; Effectiveness; Ensure; Evaluation; Experimental Designs; Fostering; Genomics; Genomics Shared Resource; Goals; Growth; Growth and Development function; Human Subject Research; Image; Immune; Immunologic Monitoring; Immunotherapeutic agent; Individual; Infrastructure; Institutes; Journals; Learning; Life Cycle Stages; Malignant Neoplasms; Mission; Molecular Target; Monitor; Multi-Institutional Clinical Trial; Play; Population Sciences; Positioning Attribute; Preventive; Procedures; Process; Protocols documentation; Publications; Recommendation; Reporting; Reproducibility; Research; Research Design; Research Personnel; Research Project Grants; Resource Sharing; Resources; Role; Safety; Sample Size; Science; Southwest Oncology Group; Statistical Data Interpretation; Statistical Methods; Structure; System; Technology; Testing; Therapeutic; Training and Education; Vision; Washington; Work; anticancer research; base; cancer clinical trial; cancer prevention; computational platform; data management; design; experience; genetic technology; imaging modality; improved; innovation; meetings; member; model development; multidimensional data; new technology; novel; operation; phase 1 designs; phase III trial; precision medicine; programs; recruit; response; satisfaction; targeted agent; tool; translational scientist; trial design; web portal

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.

生物统计共享资源 主任：森元美博士 摘要/项目摘要 奈特癌症研究所 (Knight) 生物统计共享资源 (BSR) 是一个管理共享的癌症中心 资源的总体使命是通过生物统计合作和咨询影响癌症。 BSR的愿景是为基础、临床、人群提供全面、综合的生物统计学支持 骑士大学的科学和转化癌症研究人员。 BSR 促进协作和团队科学 努力成为癌症研究团队不可或缺的一部分，并在整个生命周期提供统计支持 研究项目从概念开发到出版的整个过程。除了提供支持之外 个别研究人员，BSR 为其他 Knight 支持的共享资源提供统计咨询， 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 积极参与癌症研究领域的教育和培训 计划，通过研讨会和讲习班、期刊俱乐部、部门大查房和特定研究 计划会议。 作为我们最大限度地提高资源结构有效性的承诺的一部分，骑士投资了 BSR 中的大量资源用于建设专业知识和能力。这一承诺体现在重大的 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）的 1,394,432 美元 2015 年 - 2016 年 6 月）。为了应对未来五年的预期增长轨迹，一位顾问 2014 年 9 月聘请进行全面的外部评估，评估用户满意度， 运营流程和程序以及人员配置。评估完成后，BSR 制定 五年增长和发展计划，以确保为现有研究人员提供高质量的生物统计支持，例如 以及骑士正在招募的大量新调查员。此外，随着骑士继续 投资新技术，包括高通量“组学”技术、成像、免疫监测和 基于细胞的技术，BSR 需要先发制人地了解新技术生成的数据 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 落实工作组建议的资源，包括增加人员配置以协助 单位的业务经营活动；开发更稳健的人员配置模式；开发一个基于网络的 门户，可轻松与用户交互和沟通，提供项目管理工具，并跟踪人员配置和 使用指标；并招聘额外的博士和硕士水平的生物统计学家。由此产生的额外进球 该计划包括扩大第一阶段的设计专业知识；将生物统计人员整合到特定疾病中 研究团队改善与研究人员的早期合作；以及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，Knight 扩大了与癌症研究和生物统计 (CRAB) 的合作，CRAB 是一家非营利组织 实体位于华盛顿州西雅图。作为 SWOG 的长期统计和数据协调中心， CRAB 是设计、管理和分析治疗性和预防性癌症临床试验的全国领先者。 与 CRAB 的合作极大地增强了我们的能力和专业知识范围。关系有 为奈特临床和转化研究人员提供了立即接触经验丰富的资深癌症患者的机会 拥有多中心临床试验、III 期试验设计和早期检测试验等专业知识的生物统计学家。 BSR 由癌症预防和控制成员 Motomi (Tomi) Mori 博士指导。 BSR 非常高 被癌症研究人员所利用，并持续展现出关键的科学贡献。 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支持。