First-in-Human OUS: Practical Considerations That Matter.

First-in-human studies succeed or fail long before the first patient is enrolled, and the deciding factors are rarely the protocol or the paperwork.

First-in-human studies are not won by perfect protocols or regulatory theater. They succeed through clarity of intent, disciplined simplicity, and the right people making good decisions under uncertainty. This MasterClass focuses on the practical realities of designing, launching, and executing FIH medical device studies outside the United States, where speed, iteration, and judgment matter as much as formal process.

Drawing on real-world experience across multiple early-stage programs, Dr. Lance Black walks through what actually drives success in OUS FIH trials: defining the right clinical question, avoiding the trap of false precision, selecting investigators and CROs based on execution rather than credentials, and designing studies that prioritize learning over premature validation. The session addresses why OUS settings can accelerate early clinical learning, how to navigate regulatory and ethics…