Clinical relevance refers to the ability of a therapy to improve how the patient feels, functions, and/or survives. More specifically, a therapy is clinically relevant if it provides a positive benefit from a patient’s perspective and the benefit is statistically significant and outweighs any potential harm or risk of harm. For an endpoint in a clinical trial to be clinically relevant, it must be able to capture and measure the potential benefit.
U.S. Food and Drug Administration (FDA) Patient-Focused Drug Development Glossary
The importance of determining the clinical significance of research results in physical therapy clinical research [2018 published article]