Posted by Michael Wonder on 21 Jul 2016
Proposals to revise guidance on first-in-human clinical trials
21 July 2016 - Comments invited on a concept paper on changes intended to support best practices.
The EMA, in cooperation with the European Commission and the Member States of the European Union, is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. These changes are outlined in a new concept paper which has been released for public consultation. Comments on the proposals should be sent to FIH-rev@ema.europa.eu until 30 September 2016 using the form provided.
Clinical trials are essential for the development of medicines and without them patients cannot gain access to new potentially life-saving medicines. EU and international guidelines are in place to ensure that first-in-human clinical trials are conducted as safely as possible. These guidelines include the requirement for extensive studies, including in animals, to gather information about a medicine before it is given to humans.
