Defintion of EAG type trial (Expert Advisory Group)

[drlyncorry]

With reference to MHRA accreditation for Phase 1 units; what is the defintion of an EAG type trial? I note reference to both EAG type trials AND FIH studies.

Or asking in an other way - when completing a risk assessment how does one decide if a study requires EAG review?

Thanks

[20349546]

It's a sub-set of FIH trials. Examples given are:

• mode of action involves a target that is connected to multiple signalling pathways (target with pleiotropic effects), e.g. leading to various physiological effects or targets that are ubiquitously expressed
• compound acts (directly or indirectly) via a cascade system where there may be an amplification effect which might not be sufficiently controlled by a physiological feedback mechanism
• compound acts (directly or indirectly) via the immune system with a target or mechanism of action which is novel or currently not well characterised
• is novelty in the structure of the active substance e.g. a new type of engineered structural format such as those with enhanced receptor interaction as compared with the parent compound
• level of expression and biological function of the target receptor may differ between healthy individuals and patients with the relevant disease
• is insufficient available knowledge of the structure, tissue distribution, cell specificity, disease specificity, regulation, level of expression and biological function of the human target, including down-stream effects
• compound acts via a possible or likely species specific mechanism or where animal data are unlikely to be predictive of activity in humans

Source: https://www.gov.uk/guidance/clinical...-expert-advice, additional details here.
The original scope, established following the Duff report, can be found here.