Blinding/Masking & Unblinding Plans: Building and Protecting the Blind in Clinical Trials
Blinding/Masking & Unblinding Plans: Building and Protecting the Blind in Clinical Trials Designing Masking Strategies and Unblinding Controls That Withstand Inspection Why Masking Matters: Bias Pathways, Terminology, and Regulator Expectations Blinding (masking) is the operational firewall that protects estimates from performance and assessment biases. When clinicians, participants, or assessors know treatment assignment, conscious and unconscious…