EMA issues revized guideline on first-in-human clinical trials

The European Medicines Agency (EMA) has revised its guidance on first-in-human clinical trials to further help stakeholders identify and mitigate risks for trial participants.

The EMA’s action was largely prompted by a Phase I clinical study, conducted by French clinical research organization Biotrial, which resulted in the death of one enrolled subject and neurological injury to four others. The study had focused on BIA 10-2474, an Investigational New Drug (IND) manufactured by Portugal’s largest drugmaker Bial.

First-in-human trials are a key step in medicines development, where a medicine already tested in vitro, in animals or in other preclinical studies is administered to people for the first time. Participants in these trials, often healthy volunteers, face an element of risk as the ability of researchers to predict the effects of a new medicine on people is limited before it is actually studied in humans. Only on very rare occasions, however, have participants experienced serious harm.