The growing uptake of patient experience data in clinical development programs is reflected in the fourth of four methodological guidance document on patient-focused drug development, a draft guidance on “Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making” that touches on a wide range of issues and considerations that have arisen in the course of the maturation of patient-focused drug development from a set of goals to an increasingly established aspect of new drug applications.
The new PFDD document poses situations and points to consider drawn from the FDA’s experience with patient experience data in a growing number of drug reviews