Evolution of Cross-Sectional Survey Protocol Quality Over Time: A Case Series of Index U.S. REMS Knowledge Survey Protocols (2007–2020)

• Published in: Drug safety Vol. 46; no. 11; pp. 1073 - 1087
• Main Authors: Toyserkani, Gita A., Ewusie, Samuel B., Turk, Philip, Quick, Janifer, Morrato, Elaine H.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.11.2023; Springer Nature B.V
• Subjects: Content analysis; Cross-Sectional Studies; Drug Safety and Pharmacovigilance; FDA approval; Human subjects; Humans; Knowledge; Medicine; Medicine & Public Health; Original Research Article; Performance evaluation; Pharmaceutical Preparations; Pharmacology/Toxicology; Pharmacovigilance; Polls & surveys; Prescription drugs; Product safety; Risk assessment; Risk Assessment - methods; Science; Stakeholders; Statistical analysis; Statistical models; Statistics; Surveys; United States; United States Food and Drug Administration; United States; United States > US

Introduction Surveys are commonly used to assess effectiveness of FDA-required risk evaluation and mitigation strategies (REMS) for drugs and biologics in the United States. Objective The aim of this study was to assess the scientific rigor of REMS knowledge survey protocols submitted to FDA and com...