Phase IV trials also known as post-marketing surveillance, occur after the FDA approves a new treatment. Studies are conducted to answer any questions about the marketed product’s long-term safety and effectiveness. Questions answered can include: Does the treatment produce any rare side effects that haven’t been recorded yet? Do some side effects only arise after a person has taken the treatment for a lengthy period of time? Does the treatment’s effectiveness wane over time? How well does the treatment work when combined with other treatments?
Other aspects may be examined in Phase IV trials as well – such as a comparison to other available treatments, quality of life issues, and cost-effectiveness.
Companies that sell Phase IV Clinical Research Organizations (Phase IV CRO)
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