Editor’s Choice

The Bial 10-2474 Phase 1 Study—A Drug Development Perspective and Recommendations for Future First-in-Human Trials

This month’s editor’s choice article reviews using previously unavailable data, the incident with the drug Bial-10-2474 and the resultant death of a healthy volunteer in 2016. The study conducted by Biotrials was a multiple ascending dose study in healthy volunteers. The author of this manuscript, an individual who has been involved with drug development for decades, reviews and analyzes the issues involved with this study and offers expert recommendations. The paper is not meant to be a complete review of the topic, but meant to open a discussion about phase I study conduct.

-- Philip Chaikin,