| ▲ | randycupertino 7 hours ago | |
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. | ||