Measuring What Matters to Patients in Dermatology Drug Development: A Regulatory Perspective

Selena R Daniels; Kendall A Marcus; Robyn Bent; Elektra Papadopoulos

doi:10.1016/j.det.2022.03.002

Measuring What Matters to Patients in Dermatology Drug Development: A Regulatory Perspective

Dermatol Clin. 2022 Jul;40(3):333-337. doi: 10.1016/j.det.2022.03.002. Epub 2022 Jun 1.

Authors

Selena R Daniels¹, Kendall A Marcus², Robyn Bent³, Elektra Papadopoulos⁴

Affiliations

¹ Division 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. Electronic address: selena.daniels@fda.hhs.gov.
² Division of Dermatology and Dentistry, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903, USA.
³ Patient Focused Drug Development, Office of Center Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903, USA.
⁴ Division 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.

PMID: 35750416
DOI: 10.1016/j.det.2022.03.002

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.

Keywords: Clinical outcome assessments; Dermatology; Measurement; Observer-reported outcomes; Patient-centered; Patient-focused drug development; Patient-reported outcomes; Regulatory.

Published by Elsevier Inc.

Publication types

Review

MeSH terms

Dermatology*
Humans