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

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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.