What is a SUSAR?

Definition:

A SUSAR is a Suspected Unexpected Serious Adverse Reaction report, to detail adverse events encountered by test subjects participating in a clinical drug trial. They are defined by the US EPA as "Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment."

The list of qualifying events that require filing of a SUSAR are:

Death

A life threatening episode requiring immediate intervention

An event resulting in hospitalization or that prolongs existing hospitalization

Events resulting in persistent or significant incapacitation or disability

A congenital anomaly or birth defect

An episode that requires intervention to prevent the above and/or permanent impairment or damage

SUSARs must be reported during clinical trials but are often insufficiently described in public reports describing new drugs.

_Sources:

Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). (August 25, 2007). "Guideline for Industry - Clinical safety data management: definitions and standards for expedited reporting." FDA Center for Drug Evaluation and Research.

Also Known As: Some countries, such as India or the UK, may refer to an adverse event as a Suspected Adverse Drug Reaction (SADR).

Examples: Because the clinical trial subject had a serious seizure, investigators of the new drug had to file a SUSAR.