TAS::75 0849::TAS FACILITATING THE TRANSFER OF STATISTICAL METHODOLOGY INTO PRA

TAS::75 0849::TAS 促进统计方法向 PRA 的转移

• 批准号: 8166428
• 负责人: DAN ANBAR
• 金额: $ 10万
• 依托单位: DANA PHARMACEUTICAL CONSULTING, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-24 至 2011-06-23
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166428
• 关键词: Clinical Trials Cooperative Group; Clinical Trials Design; Computer software; Goals; Industry; Methodology; Methods; Pharmacologic Substance; Phase; Research; Research Contracts; Research Personnel; Testing; Universities; Update; authority; base; computerized tools; design; interoperability; usability; user-friendly

The overall purpose of the project is to create a comprehensive software package of adaptive statistical design and analysis methods for which no computational tools are currently available for use by Contract Research Organizations in clinical trial design and analysis. The goal is to create a modular package that would enable periodic updates. The package will be acceptable for use in projects intended for submission to regulatory authorities and will be validated and documented to be 21 CFR Part 11 compliant.

该项目的总体目的是创建一个全面的软件包，用于自适应统计设计和分析方法，目前合同研究组织在临床试验设计和分析中没有可用的计算工具。目标是创建一个支持定期更新的模块化包。该包将可用于拟提交监管机构的项目，并将验证和记录为符合21 CFR Part 11。