Key features of clinical trial design
Framing
- Robust clinical trial design incorporates randomisation (minimising confounding and selection bias), appropriate power/sample size calculation (ensuring adequate ability to detect a true effect if present), clearly defined and clinically relevant endpoints, correct statistical significance interpretation, and, for specific research questions, crossover or factorial designs - critically appraising any trial requires assessing each of these design features rather than accepting reported results at face value
- A well-designed trial with a statistically significant result is not automatically clinically important - clinical relevance and statistical significance are related but distinct considerations requiring separate assessment
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