An endpoint is a targeted outcome of a clinical trial that is statistically analysed to help determine the efficacy and safety of the therapy being studied.
Safety endpoints in a clinical trial are critical for assessing a new treatment’s risks and side effects.
Safety endpoints track any adverse events, such as side effects, complications, or deaths, that occur during the trial. They help researchers assess how well patients tolerate the treatment.
Safety data from clinical trials is carefully compared against the potential benefits of the treatment to determine whether the treatment offers a favourable risk-benefit profile. This information is critical for regulatory bodies to decide whether a new treatment should be approved for wider use.
The safety endpoints measured will differ depending on the design of the study and the pathology of the disease in question. Examples include major adverse cardiovascular events, or 24h Holter electrocardiogram in cardiovascular study. More standard safety endpoints include: adverse events, serious adverse events, laboratory parameters, etc.