BIOSTATISTICS

生物统计学

基本信息

批准号：
8555217
负责人：
paul frankel
金额：
$ 5.59万
依托单位：
BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
起止时间：
1998-09-18 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8555217
关键词：
Adjuvant Adverse event Algorithms Amendment Animals Antibodies Basic Science Biometry Biostatistics Core Case Report Form Cities Clinical Clinical Data Clinical Protocols Clinical Research Clinical Research Associate Clinical Sciences Clinical Trials Clinical Trials Data Monitoring Committees Clinical trial protocol document Cohort Studies Collaborations Collection Commit Computer software Consult Consultations Data Data Analyses Data Collection Data Quality Data Reporting Databases Development Devices Dictionary Dose Ensure Evaluation Evaluation Research Good Clinical Practice Grant Guidelines Health Insurance Portability and Accountability Act Image Imagery Immunologics Immunotherapy Individual Information Technology Institutional Review Boards Internet Investigation Investigational Drugs Laboratories Lead Leadership Logic Maintenance Malignant Neoplasms Manuscripts Measures Methods Monitor Monitoring Clinical Trials Outcome Pattern Peer Review Personal Satisfaction Phase Preparation Principal Investigator Privacy Process Program Research Project Grants Protocols documentation Publications Radiation Reporting Research Research Design Research Infrastructure Research Personnel Resources Rights Role Safety Sample Size Secure Services Solid Neoplasm Standardization Statistical Models Supervision System Testing Time Toxic effect Translational Research Update Voting Writing abstracting access restrictions base biomedical informatics data format data management design experience human subject improved innovation medical specialties meetings patient safety programs protocol development quality assurance response tool

项目摘要

The Biostatistics Core serves as a centralized resource to the investigators of the Antibody Targeted Radiation and Immunotherapy for the Treatment of Solid Tumors Program Project Grant (PPG), providing biostatistical expertise and clinical research management resources to all projects. The Biostatistics Core includes two Senior Biostatisticians (one is the Core Director), 1 Staff Biostatistician, a Quality Assurance Clinical Research Associate, and a Clinical Research Associate. The Biostatistics Core provides study design, sample size projections, safety monitoring, case form development, data collection, data quality assurance, statistical programming, summary and analysis of study results, and collaboration in writing abstracts and peer-review publications. Statistical analyses are performed using SAS, S-PLUS, R software packages, and specialty software. The Biostatistics Core ensures that the proposed research hypothesis will be measured, tested, and interpreted, independent of whether the data comes from basic science, translational or immunologic studies, imaging, or clinical trials. The Biostatistics Core will also continue to provide infrastructure for the management and integration of both existing and newly collected data through consistent and compatible data handling, which is particularly important given the large amount of data collected and processed as part of the Imaging Response Assessment Team (IRAT), the IRAT workstation that will employed for this PPG, and the important cross study analysis that will be conducted. The Core will continue to have an integral role in the scientific development, execution and analysis of all projects in the PPG, including clinical trials. Core investigators have extensive experience in quantitative methods for biomedical applications, including clinical, basic and translational science studies. The Core is committed to continue its leadership role in the scientific integrity of the PPG investigations, to participating in regular project and program meetings, and to providing rigorous and innovative input on all quantitative matters arising in the projects. Their contribution to each project promotes interdisciplinary interactions and innovative hypotheses for exploration. The Biostatistics Core has been involved in study design for each specific aims of the current proposal, and will continue to be a critical component to successful conduct of the PPG.

生物统计核心作为实体瘤治疗抗体靶向放射和免疫治疗计划项目拨款 (PPG) 研究人员的集中资源，为所有项目提供生物统计专业知识和临床研究管理资源。生物统计学核心包括两名高级生物统计学家（一名是核心主任）、一名生物统计学家、一名质量保证临床研究助理和一名临床研究助理。生物统计学核心提供研究设计、样本量预测、安全监测、案例形式开发、数据收集、数据质量保证、统计编程、研究结果的总结和分析，以及撰写摘要和同行评审出版物的协作。使用 SAS、S-PLUS、R 软件包和专业软件进行统计分析。生物统计学核心确保所提出的研究假设将得到测量、测试和解释，无论数据是否来自基础科学、转化或免疫学研究、成像或临床试验。生物统计核心还将继续通过一致和兼容的数据处理为现有和新收集的数据的管理和集成提供基础设施，考虑到作为成像反应评估团队的一部分收集和处理的大量数据，这一点尤为重要（ IRAT），将用于此 PPG 的 IRAT 工作站，以及将进行的重要交叉研究分析。核心将继续在 PPG 所有项目（包括临床试验）的科学开发、执行和分析中发挥不可或缺的作用。核心研究人员在生物医学应用定量方法方面拥有丰富的经验，包括临床、基础和转化科学研究。核心致力于继续在 PPG 调查的科学完整性方面发挥领导作用，参加定期的项目和计划会议，并就项目中出现的所有定量问题提供严格和创新的投入。他们对每个项目的贡献促进了跨学科互动和创新假设的探索。生物统计学核心参与了当前提案的每个具体目标的研究设计，并将继续成为 PPG 成功实施的关键组成部分。