Statistics Core for SWOG SDMC

SWOG SDMC 的统计核心

• 批准号: 10361435
• 负责人: Michael L. LeBlanc
• 金额: $ 319.79万
• 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/10361435
• 关键词: Adherence; Biological Markers; Cancer Science; Clinical Trials; Clinical Trials Design; Computer software; Databases; Development; Ensure; Evaluation; Faculty; Goals; Immunotherapeutic agent; Information Dissemination; Lead; Manuscripts; Monitor; Phase; Phase II/III Trial; Process; Property; Reproducibility of Results; Research Methodology; Software Tools; Southwest Oncology Group; Standardization; Statistical Data Interpretation; Statistical Methods; Testing; Time; cancer therapy; data management; design; innovation; novel therapeutics; research study; secondary analysis; software development; software systems; sound; statistics; targeted agent; translational medicine; trial design

Project Summary/Abstract Statistics Core The primary goals of the Statistics Core of the SWOG SDMC are to lead the design, development, and monitoring of rigorous clinical trials and translational medicine studies by using stringent, well-tested processes. Some specific aims of the Statistics Core faculty and staff are to (a) develop and rapidly implement scientifically sound and efficient clinical trials and collaborate on abstracts and manuscripts to ensure timely dissemination of results; (b) actively monitor ongoing trials using standardized processes and software; (c) conduct and collaborate on statistical methods research, including clinical trial design and the analysis of translational medicine studies; and (d) lead secondary analyses and cross-study research using the SWOG database. The SWOG SDMC Statistics Core approach is to use designs that lead to convincing conclusions, whether for Phase II, Phase III, or translational medicine objectives that guide new cancer treatment and science. As immunotherapy and targeted agents present challenges with respect to statistical evaluation, the Statistics Core faculty develop and evaluate the statistical properties of innovative and efficient designs to advance these new therapies.

项目总结/摘要 统计核心 SWOG SDMC统计核心的主要目标是领导设计、开发和监控 通过使用严格的、经过充分测试的流程，进行严格的临床试验和转化医学研究。一些 统计核心教师和工作人员的具体目标是（a）开发和快速实施科学合理的 和有效的临床试验，并在摘要和手稿方面进行合作，以确保及时传播结果; (b)利用标准化程序和软件积极监测正在进行的审判;（c）开展和协作 统计方法研究，包括临床试验设计和转化医学研究分析; (d)使用SWOG数据库进行二次分析和交叉研究。 SWOG SDMC统计核心方法是使用能够得出令人信服的结论的设计，无论是 II期、III期或转化医学目标，指导新的癌症治疗和科学。作为 免疫治疗和靶向药物在统计评估方面提出了挑战，统计核心 教师开发和评估创新和有效设计的统计特性，以推动这些新的 治疗