Evidence · 6 min read
Randomised controlled trials: why the design matters
Randomisation distributes known and unknown confounders evenly between groups. Blinding reduces measurement bias. Together they are why RCTs sit near the top of the evidence hierarchy.
Intention-to-treat analysis includes every randomised participant in their original group, preserving the benefit of randomisation even when people withdraw or switch treatment.
A statistically significant result is not automatically clinically meaningful. A hazard ratio of 0.95 may reach significance in a very large trial while representing a difference of days.
Check the population. Trials frequently exclude older patients, those with renal impairment and those with poor performance status, so results may not generalise to the person in front of you.