Biostatistics Core

生物统计学核心

• 批准号: 10708756
• 负责人: MARINELA CAPANU
• 金额: $ 11.08万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10708756
• 关键词: Address; Attention; Bioinformatics; Biological Assay; Biostatistics Core; Clinical Data; Clinical Research; Clinical Trials; Consult; Data; Data Analyses; Data Analytics; Data Set; Dedications; Development; Ensure; Experimental Designs; Formulation; Goals; Graph; Individual; Laboratories; Leadership; Malignant neoplasm of pancreas; Manuscripts; Memorial Sloan-Kettering Cancer Center; Methodology; Methods; Modification; Molecular; Molecular Profiling; Nature; Outcome Assessment; Outcome Study; Pancreas; Population; Preparation; Procedures; Program Research Project Grants; Protocols documentation; Publications; Randomized; Reproducibility; Research; Research Design; Research Personnel; Research Project Grants; Role; Sample Size; Sampling; Science; Statistical Data Interpretation; Statistical Methods; Validation; Work; analytical method; career; comparison group; computerized data processing; data format; design; experience; human tissue; imaging modality; imaging study; laboratory experiment; member; molecular marker; novel; potential biomarker; predict clinical outcome; predictive marker; primary endpoint; radiomics; research study; secondary endpoint; translational goal; treatment response

PROJECT SUMMARY/ABSTRACT – BIOSTATISTICS CORE The role of the Biostatistics Core is to support the investigators of the Memorial Sloan Kettering Cancer Center Pancreas SPORE in the computational and statistical aspects of their research efforts, including the design and analysis of laboratory experiments, clinical trials, molecular profiling studies, and imaging studies. Prior to the initiation of all studies, Core staff will consult with SPORE investigators to discuss the underlying scientific premise and translational goals of the project, to help the investigators select the most efficient and robust analytical methods, and to estimate sample sizes to ensure adequate power to address study objectives. In laboratory experiments, 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. For clinical studies, Core members will work with SPORE investigators to outline the major scientific objectives; the population to be studied; primary, secondary, and exploratory endpoints; experimental design; analysis plans; and a targeted sample size justified in probabilistic terms. At the conclusion of the trial, data analyses will be performed to assess the outcomes of the study. For molecular studies using human tissues, Core members will closely interface with the team members performing bioinformatics analysis and will have primary responsibility for merging molecular and clinical data, and for performing appropriate statistical and bioinformatics analyses. The members of the Biostatistics Core will also work with SPORE investigators to format data for publication. For imaging studies, Core members will assess the ability of different imaging modalities to localize pancreatic cancer. Imaging studies and radiomics analysis will also be employed to identify potential biomarkers of response to treatment. As the research studies proceed, Core staff will suggest modifications to the design and analysis plans as appropriate. They will also assist investigators with the preparation of any necessary graphs and tables, the interpretation of results, the preparation of presentations and manuscripts, and will consult on the design of subsequent research. If current statistical methodology does not adequately address a research question, alternative methodologies will be developed. The experienced and collaborative Biostatistics Core is well configured to provide the SPORE with a high level of statistical leadership and support that will enhance the efficiency, quality, and quantitative rigor of its science.

项目摘要/摘要 - 生物统计学核心 生物统计学核心的作用是支持纪念斯隆·克特林癌中心的研究人员 胰腺孢子在其研究工作的计算和统计方面，包括设计和 分析实验室实验，临床试验，分子分析研究和成像研究。之前 所有研究的启动，核心人员将咨询孢子调查人员，讨论潜在的科学 该项目的前提和翻译目标，以帮助调查人员选择最有效，最强大的 分析方法，并估算样本量以确保足够的能力解决研究目标。 实验室实验，核心成员将协助实验设计和 研究结束时数据的分析和解释。对于临床研究，核心成员将有效 与孢子调查人员一起概述了主要的科学目标；被研究的人口；基本的， 次要和探索性终点；实验设计；分析计划；和有针对性的样本量合理 用概率术语。在试验结束时，将进行数据分析以评估 研究。对于使用人体组织的分子研究，核心成员将与团队紧密接触 进行生物信息学分析的成员将对合并分子和 临床数据，以及进行适当的统计和生物信息学分析。成员 生物统计学核心还将与孢子研究人员合作以格式化数据以进行发布。用于成像研究， 核心成员将评估不同成像方式定位胰腺癌的能力。成像 研究和放射组学分析还将用于确定对治疗反应的潜在生物标志物。 随着研究的进行，核心人员将建议对设计和分析计划的修改为 合适的。他们还将协助调查人员准备任何必要的图表和表格 结果的解释，演示和手稿的准备，并将咨询有关的设计 随后的研究。如果当前的统计方法没有充分解决研究问题， 将开发替代方法。经验丰富且协作的生物统计学核心很好 配置为为孢子提供高水平的统计领导和支持，以增强 其科学的效率，质量和定量严格。