Shutterstock.com
The European Medicines Agency (EMA) is seeking views on changes made to its guideline governing first-in-human clinical trials.
The draft, which is out for public consultation until end of February 2017, reflects changes in clinical trial practice since the existing guideline was introduced in 2007.
The proposals also come in response to the death of a male volunteer and the hospitalisation of five others who took part in a phase I clinical trial in Rennes, France, in January 2016.
The recommendations include steps that should be taken to reduce the risk to trial volunteers, including principles behind the calculation of starting doses, dose escalation and maximum doses.
The draft lists the criteria to be considered before a trial is stopped, what to do if adverse events occur and the safety information that should be made available to trial volunteers.
The revisions also attempt to address the complexity of protocols required to deal with the practice of sponsors using a single trial to consider a multitude of factors, such as different patient age groups and single and multiple ascending doses.
Other issues reflected in the changes include better integration of pharmacokinetic and pharmacodynamic data and toxicological testing into the risk assessment and the role of non-clinical data in the definition of specific doses and intervals.
The proposals were endorsed by the EMA’s Committee for Medicinal Products for Human Use on 10 November 2016. The final guideline on first in human trials is expected to be published before summer 2017.
