Meet Ajay Duggal at Digestive Disease Week 2026 in Chicago on May 1–4

For the first time, FDA has declared that one pivotal trial plus confirmatory evidence will be its default pathway for drug approval—effectively ending the informal “two-trial” expectation that has shaped...

The traditional 3+3 dose escalation design has dominated Phase I oncology trials for over two decades (Le Tourneau et al., 2009, Kurzrock, 2021). Three patients per cohort, fixed escalation increments,...