Study design

Randomised controlled trial

A study assigning participants to intervention and comparison groups by chance.

What it means

Definition

Randomised controlled trial. A randomised controlled trial is often the strongest design for testing whether an intervention causes an outcome. Its credibility still depends on adequate size, follow-up, blinding, outcome choice and analysis.

What it can tell you

It can show how close the evidence is to a real human health outcome.

What it cannot tell you

It cannot prove that a treatment works in people unless human outcome data are available.

Headline trap

Why this matters in headlines

A small unblinded RCT with a surrogate endpoint may be less decisive than a headline suggests.