Draft qualification opinion on plasma fibrinogen as a prognostic biomarker (drug development tool) for all-cause mortality and COPD exacerbations in COPD subjects

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Download document Draft qualification opinion on plasma fibrinogen as a prognostic biomarker (drug development tool) for all-cause mortality and COPD exacerbations in COPD subjects
Reference number EMA/474186/2016
Status draft: consultation open
First published 2017-03-30
Last updated 2017-03-30
Consultation start date 2017-03-30
Consultation end date 2017-05-03
Email address for submissions qualification@ema.europa.eu

Summary

The COPD Foundation, COPD Biomarker Qualification Consortium (CBQC) has presented the background information, proposed contexts of use, and data analyses to support their proposal for the qualification of plasma fibrinogen as a drug development tool (prognostic biomarker) to identify COPD subjects at high risk for all-cause mortality or COPD exacerbations for inclusion in interventional clinical trials. The intent is to enable trials which utilize these important endpoints to be conducted more efficiently (reduced subject numbers, reduced study costs) by study sponsors with improved confidence in the study outcomes.