Core B: Clinical Trials and Statistics

核心 B：临床试验和统计

• 批准号: 10661813
• 负责人: Hao Wang
• 金额: $ 10.95万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10661813
• 关键词: Address; Adherence; Animals; Back; Bioinformatics; Biological Markers; Biology; Biometry; Biostatistics Core; Cancer Biology; Clinic; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Collection; Combined Modality Therapy; Communication Methods; Conduct Clinical Trials; Consultations; Correlative Study; Data Analyses; Data Collection; Data Element; Databases; Development; Ensure; Equipment; Faculty; Formulation; Genomics; Goals; Good Clinical Practice; Human; Human Resources; Immune System Diseases; Immunologics; Immunotherapy; Informatics; Infrastructure; Institutional Review Boards; Investigational Drugs; Investigational New Drug Application; Laboratories; Laboratory Finding; Laboratory Study; Learning; Link; Malignant neoplasm of gastrointestinal tract; Malignant neoplasm of pancreas; Manuscripts; Methodology; Methods; Monitoring Clinical Trials; Morbidity - disease rate; Oncology; Pancreatic Adenocarcinoma; Patient-Focused Outcomes; Patients; Positioning Attribute; Preparation; Process; Program Research Project Grants; Protocols documentation; Publications; Quality Control; Research; Research Design; Research Personnel; Research Project Grants; Resources; Running; Science; Secure; Service Statistics; Services; Specialist; Specific qualifier value; Statistical Models; Techniques; Testing; Toxic effect; Translations; Universities; Work; complex data; computerized data processing; data acquisition; data dissemination; data exchange; data integration; data management; data quality; design; electronic data capture system; flexibility; genomic data; high throughput analysis; improved; in vivo; innovation; laboratory experiment; medical schools; meetings; member; molecular marker; mortality; multidimensional data; preclinical study; preclinical trial; programs; sound; statistical service; statistics; stem; synergism; therapeutic target; tool; translational study

Clinical trials and Statistics Core Project Summary The Clinical trials and Statistics Core (Core B) Resource will collaborate and provide comprehensive statistics service and infrastructure support for clinical trials to all Research Projects in this proposed Program Project Grant. In addition, it will provide support for data management and integration, informatics, and computing, and assist with the identification and solution of complex data tasks arising in the course of project activities. Core members will work with project investigators across a wide spectrum of activities, encompassing formulation of the study design, data acquisition, statistical quality control, clinical trial monitoring, data analysis and interpretation, abstract and manuscript preparation, and data dissemination. Furthermore, when required by a specific project, Core personnel will develop and implement innovative customized biostatistics methodologies and tools in collaboration with investigators in the P01. The Core B Resource is housed in the Division of Biostatistics and Bioinformatics, Department of Oncology at Johns Hopkins University School of Medicine. This Division comprises an active and committed group of biostatistics and bioinformatics faculty, as well as non- faculty biostatisticians and bioinformaticians, with access to state-of-the art equipment and a broad range of expertise. Core members have a strong commitment to this P01, stemming from their long-standing collaborations with the Gastrointestinal Cancers Program. All proposed Projects make use of this Core Resource in every Aim. The primary objective of Core B is to guide and assist the project investigators in the design, conduct, and analysis of the laboratory, translational and immunologic correlative studies, and clinical trials proposed in this P01. Each project has a primary biostatistician thoroughly versed in the subject matter associated with the project, and all projects have access to the breadth of expertise provided by Core personnel. Core members also interact on a regular basis, and work closely with Administrative Core A and Genomic and Bioinformatics Core C, which contributes to interactions and synergy among the projects.

临床试验和统计核心 项目摘要 临床试验和统计核心（核心B）资源将合作并提供全面的统计数据 该计划项目中所有研究项目的临床试验的服务和基础设施支持 授予。此外，它将为数据管理和集成，信息学和计算提供支持，以及 协助在项目活动过程中识别和解决复杂数据任务。核 成员将与各种活动的项目调查员合作，包括 研究设计，数据获取，统计质量控制，临床试验监测，数据分析和 解释，抽象和手稿准备以及数据传播。此外，当 特定项目，核心人员将开发和实施创新的定制生物统计学方法论 和与P01中的调查人员合作的工具。核心B资源位于 约翰·霍普金斯大学医学院的生物统计学和生物信息学，肿瘤学系。这 部门包括一个活跃而坚定的生物统计学和生物信息学教师，以及非 - 教师生物统计学家和生物信息学家，可以使用最先进的设备和广泛的设备 专业知识。核心成员对这一P01有坚定的承诺，这是由于长期存在的 与胃肠癌计划的合作。所有提议的项目都利用此核心 每个目标的资源。 核心B的主要目的是指导和协助项目调查人员进行设计，行为和 在此提出的实验室，翻译和免疫相关研究以及临床试验的分析 P01。每个项目都有一个主要的生物统计学家，非常精通与该主题相关的主题 项目，所有项目都可以访问核心人员提供的专业知识。核心成员 也定期进行互动，并与行政核心A以及基因组和生物信息学紧密合作 核心C，有助于项目之间的互动和协同作用。