Phase III trial
In Trial design & structure
Also known as: phase 3, confirmatory trial, pivotal trial
A Phase III trial is the large, confirmatory study designed to establish whether a treatment works and how safe it is, usually against a placebo or an existing standard. It often involves hundreds to several thousand participants across many sites and countries. Its results are the core evidence in an application for marketing approval.
Example
A Phase III trial randomizes 3,000 patients across 150 sites in 20 countries and compares the new treatment with the current standard of care over 12 months.
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