Glossary Term
Blinding/Masking
Definition
Blinding, also known as Masking, is a method used in clinical trials to prevent bias by ensuring that participants, investigators, or both are unaware of which treatment group a participant is assigned to. Common types include single-blind (participants unaware), double-blind (both participants and investigators unaware), and triple-blind (participants, investigators, and analysts unaware).
Relevance to the MedTech Industry
Blinding ensures the validity and reliability of clinical trial results by minimizing biases that could arise from participants’ or investigators’ knowledge of treatment assignments. This is critical in demonstrating the true efficacy and safety of medical devices and therapies, providing robust data for regulatory approval and market acceptance.
Additional Information & Related Terms
Randomized Controlled Trials (RCTs) Often involve blinding to ensure unbiased comparison of treatment arms.
Placebo-Controlled Study Uses placebo as a comparator, typically requiring blinding to avoid bias.
Clinical Trial Design Incorporates blinding methods to enhance study robustness.
Bias The potential influence that blinding seeks to minimize in clinical trial outcomes.