So, as you have these (sometimes awkward) conversations about sample size, please do ensure that the clinical meaningfulness of the trial doesn’t get lost in the sample size samba beat!! 8/8

Whilst, of course, the trial has to be able to recruit the target number of patients, a trial must fundamentally be designed to deliver a clinically meaningful answer 4/8

We often hear of trials that show apparently clinically meaningful differences but did not detect these statistically. This is often because their sample size calculations were unrealistic - effect sizes set too large in an attempt to minimise the sample size 6/8

The term comes from the excellent Schulz & Grimes paper in the Lancet a number of years ago 3/8
www.thelancet.com/journals/lan...