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Measuring What Matters to Patients in Dermatology Drug Development: A Regulatory Perspective
Selena R Daniels1, Kendall A Marcus2, Robyn Bent3
1Division of Clinical Outcome Assessment, Office of Drug Evaluation Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903, USA.
Abstract:
Incorporating the patient voice into drug development and regulatory review process allows for the science of drug development to be more patient-centered. Dermatology is one therapeutic area where patients have the potential to provide valuable perspectives on symptoms, functional impacts, and aesthetic outcomes. Patient-reported and observer-reported outcomes play an important role in capturing concerns related to the disease or condition and its treatment. Patient experience data from well-designed trials are critical for regulatory decision-making and ultimately enable prescribers and patients to make better informed treatment decisions at the point of care.
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