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
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Thus whilst adjustments can obviously be made, the trial must ultimately be deemed possible of detecting a clinically important change eg one should not change the target difference from say a desired 5% to an implausible 20% reduction in outcome just to drop the sample size! 5/8
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
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
The common approach in critical care is to expand the the sample size by testing the treatment to a diverse set of diseases captured by a triage set of thresholds.
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This is an “RCT mod” called the “PettyBone RCT”.
This misleads clinicians. Obviously this sample size & effect size relationship is not valid in the Petty Bone RCT mod
Learn and tech the mods.