A composite endpoint is an endpoint that is a combination of multiple clinical endpoints for example: death, myocardial infarction or death in cardiovascular clinical trials. Composite endpoints can be primary or secondary.
The benefits of composite endpoints are:
- Increased statistical efficiency and precision.
- Smaller trials (which also means lower costs).
- Faster trial completion (as you are not hanging around waiting for a significant number of rare events).
The major risk to studies with composite endpoints is bias. Studies with composite endpoints should be analyzed carefully to avoid bias because of competing risks between endpoints. For example, a study on a particular stroke medication with endpoints of death or hospitalization may see a reduction in hospitalization only because of an increase in mortality. For this reason, death should always be included in a trial that studies non-fatal events (Skali et. al).
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