5.1 - Endpoints5.1 - Endpoints
The endpoints used in a clinical trial must correspond to the scientific objectives of the study and the methods of outcome assessment should be accurate (free of bias).
A wide variety of endpoints that are used in clinical trials as displayed below.
- Continuous measurements: blood pressures, weight, blood chemistry variables
- Event times: time to recurrence of cancer, survival time
- Counts: frequency of occurrence of migraine headaches, number of uses of rescue meds for asthma
- Binary endpoints: no recurrence/recurrence, major cardiac event yes or no
- Ordered categories: absent, mild moderate, severe pain, NYHA status
- Unordered categories: categories of adverse experiences: GI, cardiac, etc.
Some endpoints are assessed many times during the study, leading to repeated measurements.