TITLE: SUB POPULATIONS AND INTERMEDIATE OUTCOMES MEASURES IN COPY STUDY (SPIROMICS) - RADIOLOGY CENTER

标题：复制研究（SPIROMICS）中的亚群和中间结果测量 - 放射学中心

• 批准号: 8926504
• 负责人: ERIC HOFFMAN
• 金额: $ 12.05万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-02-01 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8926504
• 关键词: Biological Markers; Chronic Obstructive Airway Disease; Clinical; Clinical Trials; Contractor; Funding; Future; Genomics; Informatics; Iowa; Observational Study; Outcome; Outcome Measure; Participant; Patients; Phase; Phenotype; Population; Radiology Specialty; Severity of illness; Surrogate Markers; Therapy Clinical Trials; Work; cost; design; improved; programs; therapy development

SPIROMICS is an observational study of COPD patients designed to inform future development of therapies for COPD by 1) providing robust criteria for subclassifying COPD participants into groups most likely to benefit from a given therapy during a clinical trial, thereby improving the chances of successful outcome, and by 2) identifying biomarkers/phenotypes that can be used as intermediate outcomes to establish clinical benefit during therapeutic trials, thus reducing costs associated with clinical trials. UNC serves as the Genomics & Informatics Center (GIC) for the SPIROMICS program and Iowa serves as the Radiology Center. During Phase I, the contractor worked collaboratively with the Steering Committee to plan for biomarker analyses needed for the identification of potential subpopulations. The Steering Committee and the OSMB supported and approved the funding for Biomarker Analyses. Details of the biomarker analyses were to be finalized only after biospecimens were available.

螺旋学是对COPD患者的一项观察性研究，该研究旨在为COPD的未来开发提供疗法，以1）提供可靠的标准，以将COPD参与者分为最有可能在临床试验中受益于特定疗法中受益的小组，从而提高成功结果的机会，从而提高可用于确定临床型临床型在互体中的效果，从而确定临床范围的临床范围，从而确定该现象的重新构建。与临床试验有关。 UNC是苏螺旋学计划的基因组学和信息学中心（GIC），爱荷华州是放射学中心。在第一阶段，承包商与指导委员会合作，计划确定潜在亚群所需的生物标志物分析。指导委员会和OSMB支持并批准了生物标志物分析的资金。仅在可用生物测量后，才能完成生物标志物分析的详细信息。