BIOSTATISTICS CORE

生物统计学核心

• 批准号: 8555202
• 负责人: Glenn Heller
• 金额: $ 17.1万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-14 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8555202
• 关键词: Address; Area; Biostatistics Core; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Data; Data Analyses; Data Quality; Drug Formulations; Experimental Designs; Laboratories; Laboratory Research; Malignant neoplasm of prostate; Memorial Sloan-Kettering Cancer Center; Methodology; Phase; Population; Principal Investigator; Procedures; Protocols documentation; Randomized; Research; Research Personnel; Role; Sample Size; Structure of base of prostate; anticancer research; base; design; improved; member; preclinical study; primary outcome; quality assurance; research and development; research study; working group

The role of the Biostatistics Core is to support the investigators of the SPORE in Prostate Cancer in their research efforts, including laboratory experiments and the design and analysis of clinical trials. In preclinical studies, core members will assist in the formulation of the experimental design and in the analysis and interpretation of the data at the conclusion of the study. In the clinical trial design phase, a core member will conduct a protocol review with the principal investigator. Based on this review, a statistical section for the protocol will be provided, outlining major scientific objectives, population to be studied, primary and secondary endpoints, experimental design, a randomization procedure if necessary, analysis plans, and a targeted sample size justified in probabilistic terms. At the conclusion of the trial, data analyses will be performed to assess outcomes of the primary and secondary endpoints stated in the protocol. The specific aims of the Biostatistics Core are to: Aim 1: Contribute to the design and analysis of laboratory-based prostate cancer research Aim 2: Contribute to the design and analysis of clinical studies in prostate cancer Aim 3: Develop statistical methodology that will assist in the advancement of prostate cancer research

生物统计学核心的作用是支持前列腺癌 SPORE 研究人员的研究 研究工作，包括实验室实验以及临床试验的设计和分析。在临床前 研究中，核心成员将协助制定实验设计并进行分析和研究 研究结束时对数据的解释。在临床试验设计阶段，核心成员将 与主要研究者一起进行方案审查。根据这一审查，统计部分 将提供协议，概述主要科学目标、要研究的人群、主要和 次要终点、实验设计、必要时的随机化程序、分析计划和 从概率角度来看，目标样本量是合理的。试验结束时，将进行数据分析 旨在评估方案中规定的主要和次要终点的结果。 生物统计学核心的具体目标是： 目标 1：为基于实验室的前列腺癌研究的设计和分析做出贡献 目标 2：为前列腺癌临床研究的设计和分析做出贡献 目标 3：开发有助于前列腺癌研究进展的统计方法