The European Medicines Agency (EMA) is proposing changes to its existing guideline on first-in-human clinical trials. The EMA explained that the draft text published on Tuesday 15 November takes into account the lessons learned following the death of a patient in Rennes, France.
In-human clinical trials using experimental medicines are currently based on 2007 guidelines. This document of around 10 pages provides advice to laboratories, particularly with regard to the type of data necessary...