Clinical Endpoint: Substitute for Prediction of Clinical Benefit

Abstract

An endpoint is a primary or secondary outcome used to judge the effectiveness of a treatment; it is a precisely defined variable intended to reflect an outcome of interest thatis statistically analyzed. An endpoint usually specifies the sort of assessments made, the timing of those assessments, the assessment tools used and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. There are different types of endpoints used in clinical trails like primary endpoint, secondary endpoint, multiple endpoint and surrogate endpoint. Primary endpoint means the outcome or event that most accurately measures the benefit of the therapy or drug being studied and this is the most clinically important endpoint. Secondary endpoints are related to toxicity and undesired effects of the new therapy to demonstrate additional effects on the disease or condition. Multiple endpoint is useful in determining clinical advantage of drug depending on one illness side. A surrogate endpoint is a laboratory measure or a physical sign supposed to be used as a substitute for a clinically meaningful endpoint which in all fairness possible to predict clinical benefit.