FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Takes Risk-Management Approach to Initial Human Trials in Revised Guidelines

Nov. 21, 2016

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.

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