Safety Concerns Prompt EMA to Reassess Guidances
EMA is proposing a broader scope for guidelines on initial human trials to address emergent practices and safety issues linked to participant deaths.
As part of its ongoing effort to improve trial safety, the agency is suggesting revisions to a nearly decade-old guideline on mitigating risks for initial human trials. The changes were prompted by a mishap in a French study that killed one patient and hospitalized five others.
The concept paper released recommends expanding the guidance to cover more than single-dose studies, and tackle integrated protocols that combine both single and multiple dose escalations in trials.