How Do We Know It Isn't Just Luck? Biostatistics in Early Phase Trials

Every early phase trial ends with a number, and with a judgement about whether that number means anything. In this episode of Cognitio, Professor Rory Wolfe of the Monash University Clinical Trial Centre and medical statistician Dr Alan Herschtal set out how biostatistics underpins that judgement, and why it belongs at the first planning meeting rather than the last. They cover why clinical development is staged the way it is, what a p value actually tells you and what it does not, why confidence intervals carry more information than significance alone, and why getting sample size wrong is an ethical failure and not just a budget problem. The episode closes on phase one specifics: dose escalation, the three plus three design, and the questions worth asking whatever your role.