SWOG Statistics and Data Management Center

SWOG统计与数据管理中心

• 批准号: 10361433
• 负责人: Michael L. LeBlanc
• 金额: $ 958.79万
• 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/10361433
• 关键词: Advisory Committees; Biological Markers; Cancer Patient; Cessation of life; Clinical Medicine; Clinical Sciences; Clinical Trials; Clinical Trials Design; Collaborations; Collection; Conduct Clinical Trials; Data; 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; Phase II Clinical Trials; Phase III Clinical Trials; Publications; Reporting; Reproducibility; Research; Research Institute; Research Methodology; Research Personnel; Science; Software Tools; Southwest Oncology Group; Standardization; Statistical Data Interpretation; Statistical Methods; System; Time; Translational Research; anticancer research; cancer clinical trial; cancer therapy; clinical trial analysis; data management; data sharing; design; improved; indexing; innovation; meetings; mortality; novel strategies; outreach; phase III trial; precision medicine; programs; repository; software systems; 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.

项目摘要/摘要 总体组件 SWOG统计和数据管理中心（SDMC）在统计设计，数据中提供领导 NCTN临床试验的管理，分析和报告。这有助于席位的整体使命 通过癌症临床试验和转化研究可以显着改善生活。 SDMC的目标是（a）快速设计，开发和实施严格，高效的多中心 临床试验； （b）增强系统，以最佳监测正在进行的试验并确保研究的可重复性 使用跨研究的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，以将积分和集成的生物标志物纳入 临床试验； （d）与其他研究人员在统计方法研究方面合作，包括临床试验设计 以及转化医学研究的分析，重点是精确医学和挑战 评估免疫疗法； （e）通过构建链接来研究增强NCTN数据的新策略 到外部数据库，并建立一个全面的Swog临床和转化医学存储库 数据; （f）推进NCTN计划的科学和国家癌症研究所研究议程 通过参与活动提供科学领导力，与其他NCTN调查人员的合作伙伴关系 例如转向委员会，工作组，工作队，数据共享和临床科学会议。 SWOG SDMC促进了Swog和与NCTN合作伙伴的目标，以进行审判 当前的投资组合，同时还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。