5.1 - 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.