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Product Description

FDA Draft Guidance Impact on the E-PRO Industry

As some treatment effects are only known to the subject enrolled in a study, patient-reported outcome (PRO) measures have become a common metric in determining treatment efficacy and safety in clinical trials. Advances in PRO technologies, such as electronic patient diaries (e-diaries) and interactive voice response (IVR), have grown exponentially. To address these shifts in the industry, the FDA released in February its draft guidance Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. One topic addressed in the guidance is the electronic collection of patient- reported outcome (ePRO), spurred additional interest in this issue…