Dare to Dream Ball

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,...