Key features of clinical trial design - statistical significance
Definition
- Statistical significance (conventionally p<0.05) indicates a result is unlikely to have arisen by chance alone under the null hypothesis, but is a distinct concept from clinical significance (whether the effect magnitude is large enough to matter practically to patients) - trial design and reporting should address both considerations, not statistical significance alone
- A foundational trial design and reporting consideration, given the well-recognised risk of conflating statistical and clinical significance in both research reporting and clinical interpretation
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