BIOSTATISTICS CORE

生物统计学核心

• 批准号: 7318397
• 负责人: Glenn Heller
• 金额: $ 16.27万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7318397
• 关键词: Address; Area; Biological; Biostatistics Core; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Data; Data Analyses; Development; Drug Formulations; End Point; Experimental Designs; Grant; Laboratories; Laboratory Study; Memorial Sloan-Kettering Cancer Center; Methodology; Outcome; Phase; Population; Principal Investigator; Procedures; Program Research Project Grants; Protocols documentation; Randomized; Research; Research Personnel; Role; Safety; Sample Size; Translating; anticancer research; base; design; leukemia; member; pre-clinical; preclinical study; programs; research study

The role of the biostatistics core is to support the investigators of this leukemia grant 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 assist the principal investigator in the development of a clinical protocol. At the conclusion of the clinical trial, data analyses will be performed to assess outcomes of the primary and secondary endpoints stated in the protocol. In addition, retrospective data analyses will be performed to address specific clinical research questions. If the current statistical methodology does not adequately address a research question in this grant, alternative methodologies will be explored. . The specific aims of the Biostatistics Core are to: 1. contribute to the design and analysis of the laboratory studies; 2. contribute to the design and analysis of the clinical studies; - 3. develop statistical methodology that will assist in the advancement of leukemia cancer research. Relevance: The Biostatistics Core is essential to the design, ongoing review and final analysis of preclinical experiments and clinical trials to translate biological questions into experimentally testable hypotheses yielding interpretable results and to insure that planned clinical trials are feasible, invoke appropriate design and stopping rules to insure safety and are appropriately analyzed and interpreted.

生物统计学核心的作用是支持这项白血病资助的研究人员的研究工作， 包括实验室实验和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，并分析和解释 研究结束时的数据。在临床试验设计阶段，一名核心成员将协助负责人 研究者参与制定临床方案。在临床试验结束时，数据分析将 用于评估方案中规定的主要和次要终点的结局。此外，本发明还提供了一种方法， 将进行回顾性数据分析，以解决特定的临床研究问题。如果当前 统计方法不足以解决这个补助金的研究问题，替代 将探讨方法。. 生物统计核心的具体目标是： 1.有助于实验室研究的设计和分析; 2.有助于临床研究的设计和分析; 3.发展统计方法，这将有助于白血病癌症研究的进步。 相关性：生物统计学核心对于临床前研究的设计、持续审查和最终分析至关重要。 实验和临床试验，将生物学问题转化为实验可检验的假设 产生可解释的结果，并确保计划的临床试验是可行的，调用适当的设计 和停止规则以确保安全，并被适当地分析和解释。