What is clinical benefit?
Clinical benefit is the therapeutic advantage a treatment provides to patients, measured through outcomes such as symptom control, quality of life improvement, disease progression delay, or increased survival. It may be demonstrated in clinical trials or real-world settings and is central to regulatory, payer, and clinical decision-making.
Why is clinical benefit important in pharmaceutical development?
It is a foundational element of product value, informing benefit-risk assessments, pricing, reimbursement, and prescribing decisions. Demonstrating meaningful clinical benefit supports product differentiation, HTA submissions, and formulary inclusion. It also strengthens communication with healthcare professionals and patients.
