Core B: Biostatistics and Data Management Core

核心 B：生物统计学和数据管理核心

• 批准号: 10475736
• 负责人: YING LU
• 金额: $ 28.59万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-05-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10475736
• 关键词: Academic Medical Centers; Animals; Bioinformatics; Biological Assay; Biometry; Blood; Bone Marrow Transplantation; Cell Therapy; Cells; Cities; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Collaborations; Computer Systems; Consult; Consultations; Data; Data Analyses; Data Collection; Data Storage and Retrieval; Development; Elderly; Ensure; Faculty; Funding; Grant; Health; Hospitals; Human Resources; Immunologic Monitoring; Institutional Review Boards; International; Intervention; Journals; Laboratories; Marrow; Massive Parallel Sequencing; Medical; Medical Research; Methods; Mission; Monitor; Multi-Institutional Clinical Trial; Multicenter Trials; NCI Center for Cancer Research; Patients; Phase; Physicians; Policies; Preparation; Procedures; Production; Program Research Project Grants; Publications; Randomized; Reporting; Research; Research Activity; Research Assistant; Research Personnel; Schedule; Scientist; Services; Shapes; Statistical Data Interpretation; Supervision; Systems Development; T cell receptor repertoire sequencing; Technology; Thinking; Training; Translational Research; Transplantation; Universities; Work; base; bench-to-bedside translation; data access; data integrity; data management; design; experience; hematopoietic cell transplantation; leukemia/lymphoma; meetings; member; method development; next generation; pre-clinical; preclinical study; programs; protocol development; sound; transplant database; treatment planning

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.

核心B（生物统计学和数据管理核心）：项目总结/摘要 核心B支持PPG超过25年，包括核心领导（Lavori）、核心医师领导 （Lowsky）、两名生物统计学家（Narasimhan和Tamaresis）和一名临床研究协调员（Elder）， (in除了她的PPG工作），监督六个临床研究助理谁是支持斯坦福大学 大学医学中心和其他赠款提供所需的服务，以支持PPG的目标。的 核心B的领导者和两位生物统计学家在医学研究方面有数十年的经验，特别是， 临床试验设计和数据管理工作（组织、计划、管理、监查和分析） 与医学研究人员合作，包括多年与BMT合作的集体经验 investigators.核心B医师负责人Lowsky博士在开发、实施 单中心和多中心临床试验的数据收集和分析、研究完成和监查。的 核心通过利用深度专业知识支持临床和临床前项目以及提案中的核心C 在斯坦福大学的分析，以协助项目调查人员在他们的研究的各个方面。 核心B每周开会审查和计划工作，通常还有其他关键PPG人员参加。核心工作人员在 每月与所有临床研究助理、项目PI和其他临床研究者进行一次， 解决数据收集、数据流动、定义、表格设计等方面的困难和问题， 协议开发。定期安排研究者和核心B成员之间的特别会议， 根据需要每5个新项目在计划项目（根据以往的经验和准备 未来几年通过该计划支持的计划）将使用大约相同比例的核心B 工作量（各占15%），其余部分在核心C（25%）之间分配。核心有五个具体目标：1）提供 为PPG项目研究者提供动物研究和临床试验的生物统计学咨询，2）制定 通过大规模并行分析生成的TCR测序和免疫监测分析 核心C部署的测序技术，3）保持项目生成的数据的完整性，4） 分析科学报告和年度IND和DSMC提交的数据，以及5）保持广泛的BMT 数据库核心B致力于积极和持续地参与项目设计小组，以帮助确保项目目标 都是以最有科学意义的方式实现的。