EMA Takes Risk-Management Approach to Initial Human Trials in Revised Guidelines
The EMA is revising nearly decade-old guidelines on first-in-human trials after a patient died in a French study earlier this year to offer drugmakers guidance on risk management.
Previous guidelines on initial human studies focused on dose-escalation — a once common practice that involved progressively introducing patients to higher doses of a therapy. The updated document expands the scope of the EMA’s recommendations to take into account recent advancements in clinical development that have made trial protocols increasingly complex, involving multiple-escalation dose studies.
Sponsors should integrate all available non-clinical data into the overall risk assessment of initial human trials to identify potential safety concerns related to novel modes of action or toxicity, the EMA said.