What is multiplicity?
Multiplicity occurs when several comparisons or endpoints are tested within the same clinical trial, increasing the chance of finding a statistically significant result by chance alone. Common examples include multiple dose arms, endpoints, or subgroup analyses. Statistical corrections are used to control for this risk.
Why is multiplicity important in clinical trial design and interpretation?
Failure to adjust for multiplicity can lead to misleading conclusions about a drug’s efficacy. Regulatory agencies expect clear justification and control strategies for multiple testing. Addressing multiplicity ensures the credibility of results and supports stronger, more defensible claims in regulatory and scientific settings.
