Overview of Phase IV Trials and Post-Marketing Surveillance
Phase IV trials are usually conducted after marketing authorisation is granted and the medicine is in general use. Furthermore, Phase IV studies are also known as post-authorisation safety studies ( PASS) and may be voluntary or imposed by the regulatory authorities.
Objectives and Clinical Importance
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. In addition to safety monitoring, 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.
Comparative Overview of Post-Authorisation Studies
| Study Category | Primary Purpose and Requirements |
|---|---|
| Post-Authorisation Safety Studies (PASS) | Phase IV studies are also known as post-authorisation safety studies ( PASS) and may be voluntary or imposed by the regulatory authorities. They collect additional information about side-effects and safety. |
| Post-Authorisation Efficacy Studies (PAESs) | Conducted in order to complement efficacy data that are available at the time of the initial authorisation. |
Background: The Role of Non-Clinical Trials
Data from non-clinical trials is important as a predictor and decision-making tool in the medicines development process. It is strictly required that 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.