Phase IV

Phase IV refers to the stage of post-marketing surveillance in the drug development process after a drug has been approved for consumer use. This phase involves the monitoring of the drug in the general population to ensure its safety and efficacy in a larger, more diverse group of people.

Overview

Phase IV trials are also known as Post-marketing surveillance Trials. These trials involve the safety surveillance and ongoing technical support of a drug after it receives permission to be sold. The drug is tested in several thousands of patients. This allows for the detection of rare or long-term adverse effects which may not have been detected in earlier trials.

Purpose

The main aim of Phase IV trials is to check the drug's performance in real life scenarios, to study the drug's long-term risks, benefits and optimal use, or to discover any rare side effects or long term effects related to the drug. This phase can result in a drug being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.

Process

Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have expected effects in some demographic groups). The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials.

See also

• Clinical trial
• Drug development
• Pharmacovigilance