> Risk budget How does a smaller risk budget reduce the chance of type I error? Also, a lot of care would have to be taken that all smaller studies are pre-reg

> Risk budget How does a smaller risk budget reduce the chance of type I error? Also, a lot of care would have to be taken that all smaller studies are pre-registered as well as their outcomes. > Unblinding In practice, things happen that were not foreseen in the predefined analysis plan. Still, that solution may work provided that the statistical issues were solved correctly. > speed of enrolment Patient groups are often very selected, and almost all studies struggle to find sufficient participants. This leads to delay for many studies, and 1 in 10 studies are even prematurely stopped solely because they cannot find enough participants [1]. [1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4843106/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4843106/