Biostatistics and Bioinformatics Core

生物统计学和生物信息学核心

• 批准号: 10705231
• 负责人: JAMES E HERNDON
• 金额: $ 21.27万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-24 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10705231
• 关键词: Antibodies; Bioinformatics; Biometry; Bone Marrow; Brain; Brain Neoplasms; Cancer Vaccines; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Consult; Correlative Study; Data; Data Analyses; Databases; Development; Doctor of Philosophy; Ensure; Family; Flow Cytometry; Genotype; Glioblastoma; Glioma; Goals; Health system; Immunologic Monitoring; Immunologic Tests; Immunotherapeutic agent; Individual; Infrastructure; Laboratories; Leadership; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of brain; Manuscripts; Monitor; Pathology; Patients; Phenotype; Practice Management; Preparation; Primary Brain Neoplasms; Program Development; Publications; Quality Control; Randomized; Records; Regulatory T-Lymphocyte; Reporting; Reproducibility; Reproducibility of Results; Reproduction spores; Research; Research Design; Research Personnel; Research Project Grants; Resource Sharing; Resources; Role; Safety; Sample Size; Security; Services; Source; Specimen; Stains; Statistical Data Interpretation; T cell receptor repertoire sequencing; T-Lymphocyte; Test Result; Tissues; Translational Research; Universities; Vaccines; Work; biobank; career; career development; clinical infrastructure; cost effective; data integration; data integrity; data management; data quality; design; experience; improved; member; monocyte; mutant; neoantigens; novel; novel therapeutic intervention; operation; programs; quality assurance; synergism; vaccine strategy

ABSTRACT – Biostatistics and Bioinformatics Core (Core 1) The Biostatistics and Bioinformatics Core will serve as an essential central resource to support the common quantitative needs of the three translational projects (Projects 1-3) as well as research developed within the Developmental Research (DRP) and Career Enhancement Programs (CEP). Building on decades of collaborative experience with Duke Brain SPORE investigators, the Core will use their expertise to help investigators frame study objectives and to ensure rigorous research design, conduct, analysis, and inference. The Core will provide biostatistical leadership and expertise in the study design, conduct, sample size calculations, randomization, monitoring, analysis, and reporting of clinical studies in brain cancer by collaborating at all project stages, from study design to interpretation and publication of results (Aim 1). In addition, Core 1 will contribute bioinformatics expertise to the conduct, analysis, and reporting of correlative studies associated with clinical trials (Aim 2). Expertise is provided for the analysis of data from polychromatic flow cytometry, intracellular staining, and TCR sequencing data. Finally, the Core will facilitate integration of clinical, laboratory, and correlative data generated by Projects and Cores, and to promote data integrity (Aim 3). In partnership with the Administrative Core, an exemplary research culture will be promoted where the best data management practices will be used throughout the SPORE in order to ensure data integrity, provenance and security, and reproducibility of study findings. Though oversight of quality control and quality assurance is provided by the Administrative Core, each individual Core has a role in maintaining data quality and providing an infrastructure within which reliable and valid data is gathered. This Core will provide infrastructure for the Clinical Trial Operations Core (Core 2) and the Biorepository, Pathology and Immune Monitoring Core (Core 3) to collect quality data, and will be responsible for the integration of data from various sources for statistical analyses. Taken together, the Biostatistics and Bioinformatics Core's contributions to investigating the safety, activity and mechanisms of novel immunotherapeutic approaches to the treatment of patients with glioma are critical to the achieving our shared goals of improving treatment of GBM.

摘要 – 生物统计学和生物信息学核心（核心 1） 生物统计学和生物信息学核心将作为支持共同的重要中央资源 三个转化项目（项目 1-3）的定量需求以及内部开发的研究 发展研究 (DRP) 和职业提升计划 (CEP) 建立在数十年的基础上。 与杜克大学大脑 SPORE 研究人员的合作经验，核心将利用他们的专业知识来帮助 研究人员制定研究目标并确保严格的研究设计、实施、分析和推理。 核心将在研究设计、实施、样本量方面提供生物统计领导力和专业知识 脑癌临床研究的计算、随机化、监测、分析和报告 在项目的所有阶段进行合作，从研究设计到结果的解释和发布（目标 1）。 此外，核心 1 将为相关研究的进行、分析和报告贡献生物信息学专业知识。 提供与临床试验相关的研究（目标 2）用于分析多色数据。 最后，Core 将促进流式细胞术、细胞内染色和 TCR 测序数据的整合。 项目和核心生成的临床、实验室和相关数据，并促进数据完整性（目标 3). 将与行政核心合作，在最优秀的地方推广模范研究文化。 数据管理实践将在整个 SPORE 中使用，以确保数据完整性、来源 尽管质量控制和质量保证的监督是重要的。 由管理核心提供，每个单独的核心都在维护数据质量和提供 该核心将为收集可靠和有效数据的基础设施提供基础设施。 临床试验操作核心（核心 2）和生物样本库、病理学和免疫监测核心（核心 3） 收集优质数据，并负责整合各来源数据进行统计 综合分析，生物统计学和生物信息学核心对研究安全性的贡献， 治疗神经胶质瘤患者的新型免疫治疗方法的活性和机制是 对于实现我们改善 GBM 治疗的共同目标至关重要。