Report of the workshop on endpoints for cystic fibrosis clinical trials

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Download document Report of the workshop on endpoints for cystic fibrosis clinical trials
Reference number EMA/769571/2012
Status  
First published 2012-12-11
Last updated 2012-12-11

Summary

The Agency held a two-day workshop on 27-28 September 2012 on outcome measures for cystic fibrosis (CF) clinical trials. Experts in the field of CF (N=12) together with European drug regulators (N=14), representatives from 24 pharmaceutical companies, and 1 patient representative (with the second one unfortunately prevented from participation because of an acute pulmonary exacerbation) discussed and compiled current scientific evidence on outcome measures for evaluating medicines targeting CF lung disease, bronchopulmonary infection and exocrine pancreatic insufficiency.