Blinding

A methodological strategy in clinical trials designed to prevent knowledge of treatment assignment from influencing participant behavior, outcome assessment, or data analysis. Single-blind trials conceal allocation from participants only; double-blind trials conceal it from both participants and investigators; and triple-blind extends concealment to data analysts. Blinding minimizes performance bias, detection bias, and placebo/nocebo effects.

Contoh

• Double-blind placebo-controlled trial: identical-appearing tablets for active drug and placebo
• Double-dummy technique: when formulations differ (oral vs. injection), each group receives active + matched placebo
• Unblinding criteria: SAE requiring knowledge of treatment for clinical management