CORE--Biostatistics and Data Management Core

CORE--生物统计和数据管理核心

• 批准号: 7476299
• 负责人: Mei Lu
• 金额: $ 10.82万
• 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/7476299
• 关键词: Adenovirus Vector; Biometry; Biostatistics Core; Clinical; Clinical Investigator; Clinical Trials; Clinical Trials Design; Collaborations; Computers; Consult; Consultations; Data; Data Analyses; Development; Ensure; Gene Delivery; Gene Expression; Image; Laboratories; Modeling; Monitor; Phase; Reporting; Research Personnel; Statistical Models; System; Testing; Tissues; data management; design; programs; research study; therapeutic gene

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）的一般功能是支持该计划项目的基本和临床活动，以便研究研究最有效地设计，进行，监测和分析。这包括数据管理，统计建模，要测试的假设的形式化，以确保可以得出有效的结论，临床试验的设计以及数据分析。所有这些活动都是与所有项目中的实验室和临床研究人员合作进行的。具体目标是： 1。与研究人员协商和合作，以开发更好的腺病毒载体和治疗基因系统； 2。与研究人员有关成像模型的开发并进行协商，以量化组织中基因表达的体积和强度，并优化治疗基因递送； 3。在计划，进行，分析和 I/II期临床试验的报告； 4。协调项目的行为并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高级生物统计学家作为核心的PI，计算机程序员，数据经理和两个数据输入店员。