European regulator reviews first in human trial guidelines following death

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The European Medicines Agency (EMA) has launched a public consultation on proposals to change its guidance on first in human (FIH) clinical trials. 

The consultation is part of an EMA review into FIH best practice following an incident in Rennes, France, in January 2016 in which one man died and five other people were hospitalised during a phase I clinical trial. 

French authorities have investigated the tragedy, and their findings will be taken into account within the EMA review, which was announced in May 2016.

The existing EMA guideline on FIH clinical trials was published in 2007 and sets out the requirements for preclinical studies and the data needed to begin trials in humans. But the EMA says clinical trial practices have evolved since 2007 and that areas of the guideline should be amended accordingly. 

In particular, the 2007 guideline was based on a single ascending dose design for FIH trials, but the agency says practices have now changed and an increasing number of FIH and early-phase clinical trials involving multiple parts are often rolled into one trial (e.g. both single and multiple ascending dose components, food interaction studies, and inclusion of different age groups). 

The EMA also proposes that non-clinical pharmacology data, such as pharmacokinetics and pharmacodynamics, should be better integrated into the risk assessment of FIH trials to reflect current practices. These suggestions are included in a concept paper which has been released for consultation until 30 September 2016. 

A draft version of the revised guideline is expected by the end of the year.

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Citation
The Pharmaceutical Journal, PJ, August 2016, Vol 297, No 7892;297(7892):DOI:10.1211/PJ.2016.20201480