phase 4 (study) phase 4 (study)
Clinical research, that is done using an approved and available treatment, to collect more information.
Example of phase 4 (study) in a sentence
Data from phase 4 studies is used to monitor long-term safety, rare side effects, and benefits in large diverse populations, over a long time.
More Info
Phase 4 studies can be used to observe whether an approved treatment has any long-term or rare side effects that were not observed during earlier, smaller, and shorter-term studies.
In addition, phase 4 studies are designed to learn more about how effective the treatments are over time.
All post-marketing surveillance (PMS) studies are considered phase 4 studies
Other info to think about when joining a study
You may see the term phase 4 in the protocol or consent form and the study team may use the term when they are talking to you.
You could ask the study team if there are specific things they are looking for during this phase 4 study, how long it will last, and how you and the study team will keep in touch during this time.
