Primary endpoint

Primary Endpoint

The Primary Endpoint in clinical trials is the main result that is measured at the end of a study to see if a given treatment worked (what the investigators are most interested in knowing). The primary endpoint is used to determine the statistical significance of a drug or treatment's effectiveness. The primary endpoint should be specified before the study begins.

Definition

The primary endpoint of a clinical trial is the endpoint for which the trial is designed to detect a statistically significant effect. It is the most important outcome of a study, and all other outcomes are considered secondary. The primary endpoint is usually a clinical outcome, such as survival or the occurrence of a disease, but it can also be a biomarker or a surrogate endpoint.

Selection of Primary Endpoint

The selection of the primary endpoint is a critical aspect of the design of clinical trials. The choice of primary endpoint depends on the disease being studied, the treatment being tested, and the phase of the trial. The primary endpoint should be a direct measure of the clinical benefit of the treatment.

Types of Primary Endpoints

There are several types of primary endpoints that can be used in clinical trials, including:

• Clinical endpoints: These are direct measures of how a patient feels, functions, or survives. Examples include death, heart attack, and hospitalization.

• Biomarker endpoints: These are laboratory measurements or physical signs that are used as indicators of biological processes or responses to a treatment. Examples include blood pressure and cholesterol levels.

• Surrogate endpoints: These are substitutes for clinical endpoints. They are expected to predict clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. Examples include tumor size and viral load.

See Also

• Clinical trial
• Statistical significance
• Biomarker
• Surrogate endpoint

References

Primary endpoint Resources
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