EMA proposes changes to Ph I guidelines after fatal BIA 10-2474 trial

By Gareth Macdonald

- Last updated on GMT

iStock/neil stanners
iStock/neil stanners

Related tags European medicines agency Pharmacology Pharmaceutical industry Clinical trial

European authorities want to revise the guidelines covering first-in-human studies in light of the French trial in which one man died and others were hospitalised earlier this year.

The changes – detailed in a European Medicines Agency (EMA) concept paper​ this week - are designed to reflect changes to the drug development process since the current guidelines were published in 2007.

The agency said: “In recent years, the practice for conducting first-in-human clinical trials has evolved towards a more integrated approach, with sponsors conducting several steps of clinical development within a single clinical trial protocol.”

The EMA cited the increasingly common practice of carrying out single and multiple ascending dose studies, food interaction tests and proof of concept research in a trial and said changes were needed to let sponsors adopt a structure approach to such research.

BIA 10-2474 trial

The recommended changes were prompted by both a review of the existing guidelines and “the lessons learnt from the tragic incident which took place during a Phase I first-in-human clinical trial in Rennes, France, in January 2016​” according to the EMA.

The trial​ which was conducted by French contract research organisation (CRO) Biotrial on behalf of Portugal based drug manufacturer Bial resulted in the death of one volunteers and hospitalization of five others.

Authorities are still investigating the incident. However, at this stage it is believed that the protocol – which was approved by French regulator ANSM – was compliant with current guidelines on Phase I research.

The EMA invited parties interested in commenting on the proposed changes to provide feedback by the 30 September.

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