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Regulatory News | 22 July 2016 | By Michael Mezher
The European Medicines Agency (EMA) on Thursday announced plans to update its guidelines on first-in-human (FIH) clinical trials following a trial incident in France last January that left one patient dead and five others hospitalized.
The proposed revisions come after EMA launched a review of FIH trials in late May. At the time, EMA said its review would be based largely on the findings of two investigations into the fatal trial, which was conducted by French contract research organization Biotrial, on behalf of Portuguese pharmaceutical company Bial.
With the announcement, EMA also released a draft concept paper for public consultation through 30 September 2016. EMA says the concept paper will "form the basis" for a draft revision to its current guidelines, which it expects to release in late 2016.
The proposed changes are laid out in the draft concept paper, which argues for revising the current guidelines to more closely reflect how FIH trials are currently conducted.
According to EMA, FIH trials have changed considerably since its guidance was published in 2007, and often involve more factors, such as multiple ascending doses (MAD), food interaction and multiple subject groups.
"The current guideline mainly focuses on non-clinical aspects of drug development and the use of animal data and reflects the practice at the time it was developed which focused on a single ascending dose (SAD) design for first-in-human trials," EMA writes. "Since then, integration of the non-clinical data available before FIH administrations and the pharmacokinetic (PK), pharmacodynamic (PD) and human safety data emerging during a trial has also evolved."
As such, EMA says plans to extend its FIH trial guidance to cover:
EMA Press Release
Draft Concept Paper
Tags: First-in-Human, Phase I, Clinical Trials