CORE--Biostatistics and Data Management Core

CORE--生物统计和数据管理核心

• 批准号: 7107270
• 负责人: Mei Lu
• 金额: $ 9.96万
• 依托单位: HENRY FORD HEALTH SYSTEM
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7107270
• 关键词: biomedical facility; clinical trial phase I; clinical trial phase II; data management; gene expression; gene therapy; human data; statistics /biometry

The general function of the Biostatistics and Data Management Core (Core D) is to support the basic and clinical activities of the Program Project so that research studies are most efficiently designed, conducted, monitored, and analyzed. This includes data management, statistical modeling, formalization of hypotheses to be tested to ensure that valid conclusions can be drawn, design of clinical trials, and data analysis. All of these activities are carried out in collaboration with the laboratory and clinical investigators in all projects. The specific objectives are: 1. To consult and collaborate with investigators in the development of better adenoviral vectors and therapeutic gene systems; 2. To consult and collaborate with investigators on the development of imaging models to quantify the volume and intensity of gene expression in tissues and for optimizing therapeutic gene delivery; 3. To provide statistical consultation and collaboration in the planning, conducting, analyzing and reporting of Phase I/II clinical trials; 4. To coordinate project conduct and be responsible for data management and quality of clinical trials. The Biostatistics and Data Management Core will include the Senior Biostatistician as the PI for the core, a computer programmer, a data manager and two data entry clerks.

生物统计学和数据管理核心（核心D）的一般功能是支持计划项目的基础和临床活动，以便最有效地设计，实施，监测和分析研究。这包括数据管理、统计建模、待检验假设的形式化以确保可以得出有效结论、临床试验设计和数据分析。所有这些活动都是与所有项目的实验室和临床研究人员合作进行的。具体目标是： 1.在开发更好的腺病毒载体和治疗基因系统方面与研究人员进行咨询和合作; 2.与研究人员就成像模型的开发进行咨询和合作，以量化组织中基因表达的体积和强度，并优化治疗基因的传递; 3.在规划、执行、分析和 I/II期临床试验报告; 4.协调项目实施，负责临床试验的数据管理和质量。 生物统计学和数据管理核心将包括作为核心PI的高级生物统计学家、一名计算机程序员、一名数据管理员和两名数据录入员。