Dictionary

The Dictionary provides concise definitions of health economics terms, arranged alphabetically for quick reference. Use it to understand unfamiliar terminology or confirm the meaning of a specific term.

4 terms matching Surrogate Endpoint

A

Accelerated Approval
A regulatory pathway allowing a drug for a serious unmet need to gain approval based on a surrogate endpoint, with confirmatory trials required afterward.

C

Confirmatory Trial
A trial conducted after accelerated approval based on a surrogate endpoint, verifying the anticipated clinical benefit using a more definitive, patient-relevant outcome.

P

Post-Marketing Requirement
A study regulators formally mandate a manufacturer conduct after approval, often as a condition of accelerated approval granted on a surrogate endpoint.

S

Surrogate Endpoint
A trial outcome used as a substitute for a direct clinical benefit measure, such as survival, based on its expected predictive relationship to that outcome.