September 1, 2017

EMA publishes the revised guideline on first-in-human clinical trials

The EMA, in cooperation with the European Commission and the representatives of the Member States of the European Union through the EU Clinical Trials Facilitation Group (CTFG), has revised its guidance on first-in-human clinical trials, to further help stakeholders identify and mitigate risks for trial participants. This document addresses non-clinical issues for consideration prior to the first administration of an investigational medicinal product in humans. It also addresses the design and conduct of trials in the initial phase of single and ascending doses during the clinical development.

The revised guideline will come into effect on 1 February 2018.

First-in-human trials are a key step in medicine development, where a medicine already tested in vitroin animals or in other preclinical studies is administered to people, often healthy volunteers, for the first time. Even if participants in these trials face an element of risk that is difficult to predict, they have only on very rare occasions experienced serious harm. It was the case of the Bial Pharmaceuticals-sponsored Phase I trial (occurred in France in 2015), that triggered the release, on 21 July 2016, of the EMA’s concept paper on the revision of the 2007 “Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products”. The concept paper anticipated the issuance of this revised guideline, published in the draft version for consultation on 15 November 2016 and now, in the final version, on 25 July 2017.

As explained by the EMA, the guideline puts emphasis on the sponsor’s responsibility to define the uncertainty associated with the medicine tested at each step of the development and to describe how the potential risks that might arise from this uncertainty will be addressed within the design and conduct of the trial. The approach must be supported by a well-documented scientific rationale from the outset and be responsive to data emerging over the course of the trial itself.

The strategies to mitigate and manage risks for trial participants described in the guideline refer specifically to the calculation of the starting dose to be used in humans, the subsequent dose escalations and the criteria for maximum dose. 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.

EMA will make available all comments received, both on the initial concept paper and on the revised guideline, in September 2017.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
...
Read more
Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

Close
December 13, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the operational and practical implementation of Articles 13&14 and other related obligations f...
October 27, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the applicability of MDR requirements to 'legacy devices' and 'old' devices
October 19, 2021
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
September 29, 2021
EU pharmaceutical strategy: today the Commission launched a public consultation on the revision of the EU general pharmaceuticals legislation (open until December 21, 2021)
August 4, 2021
Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
Search by...
Search
Follow us on
Follow us on