New England Journal of Medicine · 2015 · 317 citations · 2 references
MedicinePharmacologyPharmacotherapyClinical PharmacologyPulmonary Function TestingPulmonologyForced Vital CapacityInterstitial Lung DiseasePulmonary AssessmentFibrotic Interstitial Lung DiseaseForced Vital Capacity ChangeForced Vital Capacity Measurement QualityPrimary Efficacy EndpointsProgressive Pulmonary Fibrosis
In 2014, the FDA approved two drugs for idiopathic pulmonary fibrosis that posed a regulatory challenge: the primary efficacy variable studied was the change in forced vital capacity, which hadn't been established as a surrogate for clinically meaningful benefit.
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