Core 3: Biostatistics

核心3：生物统计学

基本信息

批准号：
10474272
负责人：
MITHAT GONEN
金额：
$ 12.55万
依托单位：
SLOAN-KETTERING INST CAN RESEARCH
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-24 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10474272
关键词：
Address Bioinformatics Biological Specimen Banks Biometry Biostatistics Core Clinical Data Clinical Research Consult Data Data Analyses Data Analytics Databases Deposition Development Ensure Experimental Designs Formulation Genomics Goals Graph Hematologic Neoplasms Individual Laboratories Leadership Manuscripts Memorial Sloan-Kettering Cancer Center Methodology Modification Molecular Monitor Nature Preparation Publications Reporting Reproducibility Research Research Design Research Personnel Research Project Grants Role Sample Size Science Statistical Data Interpretation Statistical Methods System Time Validation Work Writing analytical method base clinical trial analysis data format design experience genome repository genomic data human tissue laboratory experiment leukemia member novel public repository translational goal

项目摘要

ABSTRACT The role of the Biostatistics Core is to support the investigators of the Leukemia SPORE in their research efforts, including laboratory experiments, molecular studies, and analysis of clinical trial and correlative data. 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 molecular studies using human tissues, Core members will closely interface with the members of the Genomics Core 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 and assist with deposition of genomic data into public repositories to facilitate validation of results by external investigators using their own analytical methods. For clinical studies, they will work with SPORE investigators to help set up effective systems to collect and track all required data. As the research project (RP) studies proceed, Core staff will review project databases and monitor the quantity and quality of data collected, and they will suggest modifications to the design and analysis plans as appropriate. When studies are finished, the Core will conduct correct and efficient data analyses. 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. We believe that this experienced and collaborative 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.

抽象的生物统计学核心的作用是支持白血病孢子研究人员的研究努力，包括实验室实验、分子研究以及临床试验和相关数据的分析。在开始所有研究之前，Core 工作人员将与 SPORE 研究人员协商，讨论潜在的问题项目的科学前提和转化目标，帮助研究人员选择最有效和最有效的稳健的分析方法，并估计样本量，以确保有足够的能力来解决研究问题目标。在实验室实验中，核心成员将协助制定实验设计以及研究结束时对数据的分析和解释。对于分子研究使用人体组织，核心成员将与基因组核心成员密切接触，并将拥有主要负责合并分子和临床数据，以及进行适当的统计和分析生物信息学分析。生物统计学核心成员还将与 SPORE 研究人员合作，格式化数据以供发布，并协助将基因组数据存储到公共存储库中，以方便外部研究人员使用自己的分析方法验证结果。对于临床研究，他们将与 SPORE 调查人员合作，帮助建立有效的系统来收集和跟踪所有必需的数据。作为研究项目（RP）研究继续进行，核心人员将审查项目数据库并监控数量和收集的数据的质量，他们将建议对设计和分析计划进行适当的修改。研究完成后，核心将进行正确有效的数据分析。他们也会协助研究人员准备任何必要的图表、结果的解释、准备演示文稿和手稿，并将就后续研究的设计提供咨询。如果当前统计方法不能充分解决研究问题，替代方法将是发达。我们相信，这个经验丰富且协作的核心配置良好，可以提供 SPORE 高水平的统计领导和支持将提高效率、质量和数量其科学的严谨性。