Core B: Biostatistics and Data Management Core

核心B(生物统计和数据管理核心)：项目摘要/摘要 核心B支持PPG已有25年之久，由一名核心领导(Lavori)、一名核心医生领导组成 (Lowsky)，两名生物统计学家(Narasimhan和Tamaresis)，以及一名临床研究协调员(年长) (除了她的PPG工作)，监督斯坦福大学支持的六名临床研究助理 大学医学中心和其他赠款，提供必要的服务，以支持PPG目标。这个 核心B的领导人和两位生物统计学家在医学研究方面拥有数十年的经验，尤其是， 临床试验设计和数据管理工作(组织、规划、管理、监测和分析) 与医学调查人员合作，包括与BMT合作多年的集体经验 调查人员。核心B医师领导，洛斯基博士，在开发、指导、 单中心和多中心临床试验的数据收集和分析、研究完成和监测。这个 核心通过利用专业知识的深度来支持临床和临床前项目以及提案中的核心C 在斯坦福大学从事分析方面的工作，协助项目研究人员进行全方位的研究。 核心B每周召开会议，审查和计划工作，经常有其他关键PPG人员参加。核心员工会议在 每月与所有临床研究助理、计划项目PI和其他临床研究人员一起工作， 解决困难和问题，例如，在数据收集、数据流、定义、表格设计和 协议开发。计划在调查人员和核心B成员之间举行频繁的临时会议， 视需要而定。计划项目中的5个新项目(根据过去的经验和准备 未来几年将通过该计划得到支持的计划)将使用与核心B大致相同的部分 努力(各占15%)，其余部分在核心C之间分配(25%)。核心有5个具体目标：1)提供 为PPG项目研究人员提供动物研究和临床试验的生物统计学咨询，2)开发 对大规模并行产生的TCR测序和免疫监测分析 核心C部署的排序技术，3)维护项目生成的数据的完整性，4) 分析科学报告和年度IND和DMC提交的数据，并5)维护广泛的BMT 数据库。核心B致力于积极和持续地参与PPG，以帮助确保项目目标 都是以最具科学意义的方式实现的。

Core B (Biostatistics and Data Management Core): Project Summary/Abstract Core B which has supported the PPG for >25 years, consists of a Core Leader (Lavori), a Core Physician leader (Lowsky), two Biostatisticians (Narasimhan and Tamaresis), and a Clinical Research Coordinator (Elder) who (in addition to her PPG work), supervises six Clinical Research Assistants who are supported by Stanford University Medical Center and other grants which provide services as needed to support the PPG aims. The leader of Core B and the two biostatisticians have decades of experience in medical research and, in particular, clinical trial design and data management work (organization, planning, management, monitoring and analysis) in collaboration with medical investigators, including many years of collective experience working with the BMT investigators. The Core B physician leader, Dr. Lowsky, has extensive experience in the development, conduct, data collection and analysis, study completion and monitoring of single center and multi-center clinical trials. The Core supports the clinical and preclinical projects and Core C in the proposal by leveraging the depth of expertise in analytics at Stanford University to assist project investigators in all aspects of their studies. Core B meets weekly to review and plan work, often joined by other key PPG personnel. The Core staff meet on a monthly basis with all clinical research assistants, the program project PI and the other clinical investigators, to resolve difficulties and problems, for example, in data collection, data flow, definitions, forms design and protocol development. Frequent ad hoc meetings between investigators and Core B members are scheduled, as needed. Each of the 5 new projects in the program project (on the basis of past experience and preparation of plans for the coming years to be supported through this program) will use about the same fraction of Core B effort (15% each) and the remainder is split between Core C (25%). The Core has 5 specific aims: 1) provide biostatistics consultation to the PPG project investigators for animal studies and clinical trials, 2) develop analytics for the TCR sequencing and immune monitoring assays generated by the massively parallel sequencing technologies deployed by Core C, 3) maintain the integrity of the data generated by the projects, 4) analyze data for scientific reports and annual IND and DSMC submissions, and 5) maintain the extensive BMT database. Core B is committed to active and continued participation in the PPG to help ensure that project Aims are fulfilled in the most scientifically meaningful manner.