First-in-human (FIH) oncology development presents high-impact strategic and operational challenges for sponsors transitioning from preclinical research to early clinical testing.
Early decisions made in FIH trials—around dose strategy, safety oversight, regulatory positioning, and trial design—often have long-term consequences that are difficult to reverse later in development. The focus is shifting from rapid execution alone to deliberate, risk-informed early-phase planning that preserves flexibility, strengthens regulatory confidence, and supports sustainable program progression.
Read our guide to explore more about:
- Which FIH decisions have the greatest long-term impact on development success- How early dose escalation and safety strategies shape regulatory expectations
- How trial design and biomarker choices influence future expansion and data value
- How early operational and governance decisions affect speed, quality, and scalability