Phase IV trial
In Trial design & structure
Also known as: phase 4, post-marketing study
A Phase IV trial takes place after a treatment has been approved and is on the market. It studies long-term safety, effectiveness in everyday practice, rarer side effects, and use in groups not well represented in earlier trials. Regulators sometimes require one as a condition of approval.
Example
After approval, the sponsor runs a large registry-based study to check whether a rare side effect seen a handful of times in Phase III occurs more often in everyday use.
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