SWOG Statistics and Data Management Center

SWOG统计与数据管理中心

• 批准号: 10643701
• 负责人: Michael L. LeBlanc
• 金额: $ 855.06万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-17 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10643701
• 关键词: Advisory Committees; Biological Markers; Cancer Patient; Cessation of life; Clinical Medicine; Clinical Sciences; Clinical Trials; Clinical Trials Design; Collaborations; Collection; Computer software; Conduct Clinical Trials; Data; Data Coordinating Center; Data Science; Databases; Ensure; Evaluation; Fostering; Funding; Goals; Immunotherapy; International; Leadership; Link; Medicare; Mentors; Methodology; Mission; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; Multicenter Trials; National Cancer Institute; Oncology; Patient-Focused Outcomes; Patients; Phase; Publications; Reporting; Reproducibility; Research; Research Institute; Research Methodology; Research Personnel; Science; Software Tools; Southwest Oncology Group; Standardization; Statistical Data Interpretation; Statistical Methods; System; Translational Research; anticancer research; cancer clinical trial; cancer therapy; clinical translation; clinical trial analysis; data management; data sharing; design; improved; indexing; innovation; meetings; mortality; novel strategies; outreach; phase III trial; precision medicine; programs; repository; statistics; tool; translational medicine; trial design; working group

Project Summary/Abstract Overall Component The SWOG Statistics and Data Management Center (SDMC) provides leadership in the statistical design, data management, analysis, and reporting of NCTN clinical trials. It contributes to SWOG's overall mission to significantly improve lives through cancer clinical trials and translational research. The goals of the SDMC are to (a) rapidly design, develop, and implement rigorous and efficient multi-center clinical trials; (b) enhance systems for best monitoring of ongoing trials and ensure reproducibility of research using cross-study standardized software and systems for statistical analysis and clinical trials reporting; (c) develop innovative statistical design and software tools for incorporating integral and integrated biomarkers into clinical trials; (d) collaborate with other researchers on statistical methods research, including clinical trial design and the analysis of translational medicine studies, with a focus on precision medicine and challenges in the evaluation of immunotherapy; (e) investigate new strategies for enhancing NCTN data by constructing linkages to external databases and building a comprehensive repository of SWOG clinical and translational medicine data; and (f) advance the science of the NCTN program and the National Cancer Institute research agenda, in partnership with other NCTN investigators, by providing scientific leadership through participation in activities such as steering committees, working groups, task forces, data sharing, and clinical science meetings. The SWOG SDMC contributes to the goals of SWOG and partners with the NCTN to conduct trials within the current portfolio, while also providing data, strategies, and useful new statistical tools to other clinical trials organizations and oncology researchers.

项目总结/摘要 总体组件 SWOG统计和数据管理中心（SDMC）在统计设计、数据管理和数据管理方面发挥领导作用。 NCTN临床试验的管理、分析和报告。它有助于SWOG的整体使命， 通过癌症临床试验和转化研究显著改善生活。 SDMC的目标是（a）快速设计、开发和实施严格有效的多中心 临床试验;（B）加强对正在进行的试验进行最佳监测的系统，并确保研究的可重复性 使用跨研究标准化软件和系统进行统计分析和临床试验报告;（c） 开发创新的统计设计和软件工具，用于将完整和综合的生物标志物纳入 （d）与其他研究人员合作进行统计方法研究，包括临床试验设计 和转化医学研究的分析，重点是精准医学和挑战， 评价免疫疗法;（e）研究通过建立联系增强NCTN数据的新策略 外部数据库，并建立SWOG临床和转化医学的综合知识库 数据;（f）推进NCTN计划和国家癌症研究所研究议程的科学， 与其他NCTN研究人员合作，通过参与活动提供科学领导 如指导委员会、工作组、工作队、数据共享和临床科学会议。 SWOG SDMC有助于实现SWOG的目标，并与NCTN合作，在 目前的产品组合，同时也为其他临床试验提供数据，策略和有用的新统计工具 组织和肿瘤学研究人员。