The European Medicines Agency (EMA) has started a appraisal of the plan that describe first-in-human clinical trials and the data needed to allow their suitable design and allow instigation. This is being done in collaboration with the European Commission and the Member States of the European Union (EU).
The evaluation will recognize which areas may need to be revised in the light of the tragic incident which took place during a Phase I first-in-human clinical trial in Rennes, France, in January 2016. The trial led to the death of one participant and hospitalization of five others.
EMA’s assessment will take into relation the findings from two in detail investigations into what went wrong during this check, one carried out by the provisional Specialist Scientific Committee (TSSC) set up by the French medicines agency ANSM and the other by the assessment générale des affaires sociales (IGAS), the inspectorate for social affairs in France.
Both reports comprise a sequence of recommendations concerning the requirements for sanction and ways of first-in-human clinical trials for further examination by the international regulatory and public health community.
EMA’s work will be the hub on best practices and direction. The objective is to agree a concept paper by July identifying areas for change and proposals to further reduce the risk of similar accidents. The concept paper will form the basis for an EU-wide review of the guidelines. This process will comprise of targeted discussions with stakeholders and a public discussion on anticipated changes shortly in 2016.
The EMA appraisal has started with two groups of experts who are carrying out preliminary work. One group is looking at pre-clinical aspects and the data needed from laboratory tests or animal studies to safely start first tests in humans. The other group is looking at clinical aspects of the design of first-in-human trials and how these could be improved to better ensure the safety of human volunteers taking part in these trials. This will lead into one EU-wide expert group discussion on review of guiding principle.
Clinical trials are vital for the improvement of medicines and without them patients cannot expand contact to new potentially life-saving medicines. In the EU, the approval and conduct of clinical trials is within the remit of the relevant authorities of the European Member States.
EU guidelines are in place to ensure that these clinical trials are conducted as safely as possible.
Severe adverse reactions in healthy volunteers such as those experiential in the trial in Rennes are extremely rare during clinical trials. Since 2005, approximately 14,700 phase I clinical trials (with participation of 305,000 subjects) have been conducted in the EU, including 3,100 first-in-human studies. Only one other rigorous incident has been previously reported in that time in the EU
Date: 27/05/2016