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

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）提供稳健的标准，用于将COPD受试者细分为临床试验期间最有可能从给定治疗中获益的组，从而提高成功结局的可能性; 2）鉴定可用作中间结局的生物标志物/表型，以确定治疗试验期间的临床获益，从而降低与临床试验相关的成本。 芝加哥大学作为SPIROMICS项目的基因组学和信息学中心（GIC），爱荷华州作为放射学中心。在第一阶段，承包者与指导委员会合作，规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。生物标志物分析的详细信息仅在生物标本可用后才能最终确定。

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.