Clinical

临床

• 批准号: 7917913
• 负责人: CHAP T. LE
• 金额: $ 11.85万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7917913
• 关键词: Animals; Biometry; Biostatistical Methods; Biostatistics Core; Cancer Center; Clinical; Clinical Trials; Collaborations; Consultations; Data Analyses; Data Collection; Databases; Ensure; Ethics; Experimental Designs; Goals; Hematologic Neoplasms; Individual; Information Systems; Preparation; Procedures; Public Health; Quality Control; Reporting; Science; Secure; Services; Societies; Statistical Data Interpretation; Statistical Study; Work; improved; informatics shared resource; man; member; operation; programs; quality assurance; sound; working group

The Biostatistics Core for this program project is staffed with members of the Biostatistics and Informatics Shared Resource of the Masonic Cancer Center. The working principles of this Core reflect those delineated in a recent report from the working group convened by the Royal Statistical Society to study statistical and scientific issues related to 'First in man Studies' (March 2007). Their views are exemplified by the quote "Statistician's input concerns matters of ethics, science, and public health, reporting standards, practicality and common sense, not just the purely methodological." In addition, the team that prepared this application will also support the critical need for sound, secure and efficient data systems and appropriate quality assurance and quality control procedures. To that end, the primary objective of the Biostatistics Core is to contribute to the science and operation of the program project by participating fully in its activities as it has for the preparation of this application. This includes assistance and direction in experimental design, quality control, data collection and management, and statistical data analysis through consultation and collaboration. The Specific Aims of the Core are as follows: SA 1: Assist in experimental designs and provide data analysis plans. SA 2: Develop new biostatistical methods when necessary and appropriate SA 3: Implement Quality Assurance (QA) plans for all data collection activities SA 4: Support existing and develop new (when necessary) database applications for data collection and integration.

该计划项目的生物统计核心由共济会癌症中心生物统计和信息学共享资源的成员组成。该核心的工作原则反映了英国皇家统计学会召集的工作组最近的一份报告中所描述的原则，该工作组旨在研究与“人类首次研究”相关的统计和科学问题（2007 年 3 月）。他们的观点可以通过引用“统计学家的意见涉及道德、科学和公共卫生、报告标准、实用性和常识等问题，而不仅仅是纯粹的方法论”来体现。此外，准备此应用程序的团队 还将支持对健全、安全和高效的数据系统以及适当的质量保证和质量控制程序的迫切需求。 为此，生物统计核心的主要目标是通过充分参与其活动（就像准备本申请一样），为该计划项目的科学和运作做出贡献。这包括通过咨询和协作在实验设计、质量控制、数据收集和管理以及统计数据分析方面提供协助和指导。 核心的具体目标如下： SA 1：协助实验设计并提供数据分析方案。 SA 2：在必要和适当时开发新的生物统计方法 SA 3：为所有数据收集活动实施质量保证 (QA) 计划 SA 4：支持现有并开发新的（必要时）数据库应用程序以进行数据收集和集成。