Endpoints and markers in clinical trials

A biological marker is a physical sign or laboratory measurement that occurs in association with the pathology of a given disease and has a potential diagnostic 

On the other hand, there are some biological markers in the cerebrospinal fluid (CSF) of patients with Alzheimer s disease showing a correlation with the severity of the disease, the extent of neurodegeneration, oxidative stress or neuroinflammation (see Chapter 7). 

The clinical endpoint is a clinically meaningful measure of how patients feel, function or survive. Investigator-rated or self-assessed rating instruments are the most frequently used clinical endpoints. A primary endpoint is the main outcome that a study protocol is designed to evaluate. The statistical power and the sample size calculation of a particular trial are determined by the primary endpoint. Depending on the purpose of a study the primary endpoint can be 

An intermediate endpoint is a clinical endpoint assessed at some stage of a study but not at its very raid. Ultimate outcome is a clinical endpoint such as survival, onset of serious morbidity or symptomatic response that captures the benefits and risks of a treatment. Admission to a nursing home could serve as an ultimate outcome in the case of a drug intended to treat outpatients with Alzheimer s disease. 

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