Core C: Biostatistics & Bioinformatics Core

核心 C：生物统计学

• 批准号: 10707987
• 负责人: MITHAT GONEN
• 金额: $ 21.24万
• 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 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10707987
• 关键词: Address; Area; Bioinformatics; Biometry; Clinical; Clinical Trials; Clinical Trials Design; Collaborations; Computing Methodologies; Data; Data Analyses; Development; Doctor of Philosophy; Experimental Designs; Formulation; Genomics; Individual; Laboratories; Laboratory Research; Malignant neoplasm of prostate; Memorial Sloan-Kettering Cancer Center; Methodology; Outcome Assessment; Phase; Population; Procedures; Protocols documentation; Randomized; Research; Research Methodology; Research Personnel; Role; Sample Size; Statistical Data Interpretation; advanced prostate cancer; anticancer research; clinical trial analysis; data quality; design; improved; laboratory experiment; member; pre-clinical; preclinical study; preclinical trial; primary endpoint; quality assurance; secondary endpoint; trial design; working group

PROJECT SUMMARY/ABSTRACT The role of the Biostatistics and Bioinformatics Core is to support investigators of the SPORE in Prostate Cancer at Memorial Sloan Kettering Cancer Center in their research efforts, including laboratory experiments, the design and analysis of clinical trials, and bioinformatics analyses. For 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 studies. A core member will conduct a protocol review with SPORE investigators during the clinical trial design phase. Based on this review, we will provide a statistical section for the protocol, 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. A similar strategy will be employed for genomic analyses and core members will be integrated to the individual studies early on, remain involved, and carry full responsibility for all quantitative aspects.

项目概要/摘要 生物统计学和生物信息学核心的作用是支持前列腺 SPORE 的研究人员 纪念斯隆凯特琳癌症中心的癌症研究工作，包括实验室实验， 临床试验的设计和分析以及生物信息学分析。对于临床前研究，核心成员将 协助制定实验设计以及分析和解释数据 研究结论。核心成员将在实验期间与 SPORE 研究人员一起进行方案审查 临床试验设计阶段。根据这次审查，我们将为该协议提供一个统计部分，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、分析计划以及概率合理的目标样本量 条款。试验结束时，将进行数据分析以评估主要结果和 方案中规定的次要终点。类似的策略将用于基因组分析和核心 成员将尽早融入个人研究，继续参与，并对所有研究承担全部责任 数量方面。