Biostatistics Shared Resource

生物统计学共享资源：项目总结/摘要 生物统计共享资源（BSR）的总体目标是为弗吉尼亚联邦提供 梅西大学癌症中心（MCC）成员与专家统计咨询和合作 支持其基础，转化和临床癌症研究活动的服务。这一目标将得到实现 通过在MCC成员研究的各个阶段提供生物统计支持和指导， 实验设计、样本量要求和把握度计算、研究计划制定、 统计设计、随机化和分层程序的开发、中期分析， 分析已完成的结果，介绍研究结果，并发表科学出版物，以传播新的 癌症的预防和治疗。BSR为MCC成员提供所有4项研究 所有癌症中心成员都可以获得BSR服务。该资源由Kellie J. Archer博士，并为7名教师生物统计学家和1名MS生物统计学家（2.3 FTE）提供部分支持 共计）。机构工作人员在随机临床试验的适应性研究设计、贝叶斯和 分层建模，成像数据分析，纵向数据分析，评价的统计方法 诊断测试和来自高通量组学平台的数据分析。BSR的教师也参加了 通过方案审查和监测委员会监督MCC临床试验和研究方案 并支持数据和安全监测委员会。强调协作的性质 通过确保适当的生物统计专业知识， 可用于临床试验设计、基础科学研究设计和支持项目开发。在 除了在研究项目，临床试验和拨款申请的各个层面上进行合作外，教职员工 在BSR也有助于癌症相关的研究进行方法研究，适用于 直接用于MCC的项目研究。他们还通过研讨会和个人培训来培训调查人员。 会议，并通过临床研究和生物统计学教育博士后科学家和临床研究员 研究生学位集中度。BSR是MCC管理的资源。MCC成员可以联系BSR 成员随时通过电子邮件，和BSR成员可在校园会议从上午8：00通过 周一至周五下午5：00支持持续的合作，不包括准备赠款申请 通过合作赠款或合同，其中规定了成本回收。没有用户付费。在 2015年，BSR为48个MCC成员提供了服务。BSR提供的服务显著增加了 由于服务实际上不是通过其他供应商获得的， 构成MCC成员研究工作的一个紧密结合的组成部分。

BIOSTATISTICS SHARED RESOURCE: PROJECT SUMMARY/ABSTRACT The overall objective of the Biostatistics Shared Resource (BSR) is to provide Virginia Commonwealth University Massey Cancer Center (MCC) members with expert statistical consultation and collaborative services in support of their basic, translational, and clinical cancer research activities. This objective will be met by providing biostatistical support and guidance to MCC members at all stages of their research including experimental design, sample size requirements and power calculations, study plan development, analysis of the the statistical design, development of randomization and stratification procedures, interim analyses, analysis of completed results, presentation of research findings, and scientific publication to disseminate new findings in the prevention and treatment of cancer. The BSR serves MCC members from all 4 research programs and all cancer center members have access to BSR services. The resource is directed by Kellie J. Archer, PhD, and provides partial support for 7 faculty biostatisticians and one MS biostatistician (2.3 FTEs total). Facility staff are broadly skilled in adaptive study designs for randomized clinical trials, Bayesian and hierarchical modeling, analysis of imaging data, longitudinal data analysis, statistical methods for evaluating diagnostic tests, and analysis of data from high-throughput ‘omics platforms. BSR faculty also participate in the oversight of MCC clinical trials and research protocols through the Protocol Review and Monitoring Committee and additionally support the Data and Safety Monitoring Committee. The emphasis on the collaborative nature of the BSR contributes substantially to MCC research by ensuring appropriate biostatistical expertise is available for clinical trial design, basic science study design, and for supporting project development. In addition to collaborating at all levels in research projects, clinical trials, and grant applications, faculty members in the BSR also contribute to cancer-related research by conducting methodological research that applies directly to programmatic research at MCC. They also train investigators through seminars and individual sessions, and educate postdoctoral scientists and clinical fellows through the clinical research and biostatistics graduate degree concentration. The BSR is an MCC-managed resource. MCC members may contact a BSR member anytime by email, and BSR members are available for meetings on campus from 8:00 AM through 5:00 PM Monday through Friday. Ongoing collaboration, exclusive of preparing grant applications, is supported by collaborative grants or contracts, which provides for cost recovery. There are no user fee chares. In CY2015, the BSR provided services to 48 MCC members. The services provided by the BSR add significant value for MCC members as the services are not practically obtained through alternative vendors and very often constitute a tightly integrated component of MCC member’s research studies.