Know the questions a skeptical FDA reviewer will probe — before you're in the room.
A trial reports p = 0.03. As this is less than 0.05, it meets the well-known criterion for being statistically significant. But is the trial outcome also credible? That depends on what you mean by credible—and on information the p-value alone cannot provide. Statistical significance tells you the
The last post argued that how you randomize is a design decision most biostatisticians treat as settled before the interesting work begins. REMAP-CAP showed what happens when that decision is taken seriously. The carat package showed that even standard covariate-adaptive randomization has inferential consequences most of us aren't
A simulation study on why historical control borrowing reduces sample size, and what happens when the history is wrong
