TITLE: SUB POPULATIONS AND INTERMEDIATE OUTCOMES MEASURES IN COPD STUDY (SPIROMICS) - GENOMICS & INFORMATICS CENTER

标题：慢性阻塞性肺病研究中的亚群和中间结果测量（SPIROMICS）-基因组学

• 批准号: 8926505
• 负责人: DAVID COUPER
• 金额: $ 94.95万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 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/8926505
• 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.

SPIROMICS是一项针对COPD患者的观察性研究，旨在通过以下方式为COPD治疗的未来发展提供信息：1)提供可靠的标准，将COPD参与者细分为最有可能从临床试验中获益的组，从而提高成功结果的机会；2)识别可作为中间结果的生物标志物/表型，以在治疗试验中建立临床获益。从而降低与临床试验相关的成本。