Study Endpoint

Study endpoint refers to a predefined measure or outcome used to assess the effectiveness or safety of the intervention being studied. Synonyms for study endpoint include study outcome, variable, or outcome measure. These terms are often used interchangeably to describe the specific indicators that determine the success or failure of a clinical study. Depending on the phase of the study, endpoints refer to efficacy and/or safety measures. The selection of appropriate endpoints is a critical part of clinical trial design, as they guide data analysis and help draw meaningful conclusions about the intervention's impact.

Study endpoints can be classified into primary and secondary endpoints.
The primary endpoint is the main outcome that a study aims to assess and is used to determine whether the intervention has the desired effect. In late study phases, common primary endpoints include responder rates, disease progression, or mortality rates, depending on the disease being treated.
Corresponding secondary endpoints are additional measures that provide further insight into the intervention's effects, such as changes in quality of life, adverse events, or other related clinical outcomes.

In early phase studies, the primary endpoints usually refer to safety measures such as the frequency of adverse events or changes in laboratory values.

In regulatory context, endpoints play a crucial role in determining whether a treatment meets the necessary criteria for approval by health authorities. Well-defined and measurable endpoints ensure the clinical trial provides robust, reliable data that support informed medical decision-making.