What is clinical meaningfulness?
Clinical meaningfulness is the extent to which a treatment’s benefits translate into tangible improvements in patient health, function, or quality of life. It moves beyond statistical significance to assess whether changes are perceived as valuable by stakeholders. Examples include improvements in daily functioning, symptom burden, or survival time.
Why is clinical meaningfulness important in medical and access strategy?
Demonstrating clinical meaningfulness supports engagement with regulators, HTA bodies, and prescribers. It can strengthen the case for value-based pricing and real-world adoption. For Medical Affairs, it provides a critical link between clinical trial outcomes and patient-centered communication.
