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Phase IV clinical trials: What else do we need to know?

Drugs approved by the FDA are often watched over a long period of time in phase IV studies. Even after testing a new medicine on thousands of people, all the effects of the treatment may not be known. Some questions may still need to be answered. For example, a drug may get FDA approval because it was shown to reduce the risk of cancer coming back after treatment. But does this mean that those who get it are more likely to live longer? Are there rare side effects that haven’t been seen yet, or side effects that only show up after a person has taken the drug for a long time? These types of questions may take many more years to answer, and are often addressed in phase IV clinical trials.

Key points of phase IV clinical trials

• Phase IV studies look at drugs that have already been approved by the FDA. The drugs are available for doctors to prescribe for patients, but phase IV studies might still be needed to answer important questions.
• These studies may involve thousands of people.
• This is often the safest type of clinical trial because the treatment has already been studied a lot and has likely been given tot many people. Phase IV studies look at safety over time.
• These studies may also look at other aspects of the treatment, such as quality of life or cost effectiveness.

You can get the drugs used in a phase IV trial without being in a study. And the care you would get in a phase IV study is very much like the care you could expect if you were to get the treatment outside of a trial. But in phase IV studies you’re helping researchers learn more about the treatment and doing a service to future patients.