Phase IV Trials

Phase IV trials are usually conducted after marketing authorisation is granted and the medicine is in general use.

Phase IV studies are also known as post-authorisation safety studies (PASS) and may be voluntary or imposed by the regulatory authorities. The possibility also exists of requesting the marketing authorisation holder to conduct post-authorisation efficacy studies (PAESs) in order to complement efficacy data that are available at the time of the initial authorisation. Phase IV studies collect additional information about side-effects and safety, long-term risks and benefits, and/or how well the medicine works when used widely.

: The four phases of clinical development differ in terms of their objectives and features.

Synonyms:

Phase IV Study, Phase IV Studies, Post-marketing surveillance study, post-marketing surveillance studies, Phase 4

Glossary: Post-authorisation efficacy study [PAES]
Glossary: Post-marketing surveillance study [PMS]
The predictive value of non-clinical testing
Data from non-clinical trials is important as a predictor and decision-making tool in the medicines development process. Adequate and satisfactory non-clinical results are required before a medicine may be administered to healthy human volunteers, and non-clinical data is closely reviewed before a medicine is allowed to enter the market.

Related Terms:

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