Phase IV Trials

Phase IV clinical trials are conducted after the FDA approves the marketing of a drug by a pharmaceutical company. Phase IV research is utilized to examine the long-term effects of drugs over an extended time period for a larger group of people. Phase IV studies are performed to continuously discover more information about these new drugs post marketing.

Who Participates in Phase IV Research?

Participants in Phase IV clinical trials are typically patients who have been taking the drug for an extended duration of time while under supervision. Phase IV research is commonly conducted in physicians’ offices, since this is where patients receive regular medical care and prescriptions are given out monthly.

Why is Phase IV Research Conducted?

Phase IV clinical trials often test the drug’s effect on certain types of people, such as pregnant women, or to test the drugs’ interaction with other medications patients are taking. Phase IV research can also be used to find new markets for the drug for competitive analysis. Since Phase IV studies apply to a much larger group of people over a much longer period of time, the long-term effects and unique effects on different populations can be more accurately measured and detected.