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- W2113726442 abstract "Biomarker development in chronic obstructive pulmonary disease (COPD) is a nascent field, in part because of the complexity underlying COPD pathogenesis. The objective of this review is to provide examples of how biomarkers may be effectively applied in clinical trials of COPD by limiting their use to specific contexts and using them to answer well delineated questions. Types of novel outcomes or “biomarkers” that may be useful in clinical trials in COPD include analyses performed on bronchoscopically obtained samples, sputum, exhaled gases, blood, and urine and “ex vivo” assays performed using biological samples obtained from trial participants. These novel biological outcomes are rarely useful as primary end points in phase III clinical trials in COPD, because they are not typically recognized by the U.S. Food and Drug Administration or other regulatory agencies. More commonly, the applications of these outcomes include “proof-of-concept” decisions, demonstration that the intervention had the intended p..." @default.
- W2113726442 created "2016-06-24" @default.
- W2113726442 creator A5068244386 @default.
- W2113726442 date "2012-12-20" @default.
- W2113726442 modified "2023-09-26" @default.
- W2113726442 title "Novel Outcomes and End Points" @default.
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