Outcomes in Clinical Trials: European Respiratory Monograph

The traditional end-points for clinical studies of lung
diseases were based on functional parameters. Their value as surrogate markers
for disease activity and progression has been increasingly questioned by
scientists, carers, regulatory agencies and funding bodies. Novel tools and
methods with regard to biomarkers and patient-reported outcomes have made these
parameters emerge from their status as interesting secondary end-points and
become potential primary outcomes for clinical trials. Nevertheless, their
relevance and validity still needs to be proven. This issue of the European Respiratory Monograph describes
the current status regarding end-points in all relevant areas of pulmonary
medicine.