Phase III Clinical Trials → Study Goals

Phase III studies are designed to determine whether the drug candidate provides a benefit to the intended population. Safety data is also a primary endpoint in Phase III as the longer duration of the study allows researcher to evaluate more long-term side effects data, and due to the larger sample sizes, researchers are able to assess more rare side effects. The sponsor-investigators must prove that their drug candidate is at least as safe and effective as current available therapies in order to proceed and acquire market approval.

Phase III trials may be terminated for a variety of reasons including insufficient efficacy (either on its own or in comparison to current therapy), serious/unexplained adverse events, evidence for potential damage to tissue, organs, or cells, efficacy only seen in smaller populations, or excessive measures mandated for market approval.