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EMA reveals new clinical trial guidelines to reduce patient risk

Published on 28/07/17 at 09:50am

The EMA has announced its intention to introduce revised guidelines concerning the use of medicines in first in-human clinical trials in a bid to reduce potential safety risks on participants by placing greater responsibility for the trial sponsor.  

By merit of their very nature, clinical trials often present a considerable level of uncertainty for those offering to participate in them, given the then-largely unknown effects of the drug being investigated. The new guidance will push trial sponsors to define the scope of uncertainty associated with trialled drugs as part of the design of the study.

The guidance also offers direction on how to minimise this risk, such urging safe starting dosages and measured, safe dose escalations, while paying close attention to the novelty and potency of a particular treatment. It also calls for sponsors to consider and provide clear guidance on when to stop a trial, as well as what to do when confronted with adverse reactions.

“The guideline now refers specifically to the calculation of the starting dose to be used in humans, the subsequent dose escalations and the criteria for maximum dose – in order to mitigate and manage risks for trial participants,” a statement from the EMA read. “Guidance is also provided on criteria to stop a study, the rolling review of emerging data with special reference to safety information for trial participants, and the handling of adverse events in relation to stopping rules and rules guiding progress to the next dosing level.”

The changes were the result of a public consultation in November 2016, due to the death of one volunteer in a French Phase 1 trial that same year, thought to be the result of dosing. The revised guideline is to be released in September, based on “well-documented scientific rationale from the outset and be responsive to data emerging over the course of the trial itself.”

Matt Fellows

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