BOIN (Bayesian Optimal Interval) trial design is already very common in Phase I studies across therapeutic areas.
Biggest benefit I see from this guidance is support for rare disease trials, where patients are harder to find. Also regulatory bodies will be taking a closer look at stratification groups when it comes time for approval, so sponsors need to keep a super close eye on ensuring even enrollment and preventing misstrats.
Biggest benefit I see from this guidance is support for rare disease trials, where patients are harder to find. Also regulatory bodies will be taking a closer look at stratification groups when it comes time for approval, so sponsors need to keep a super close eye on ensuring even enrollment and preventing misstrats.