Endpoint adjudication in cardiovascular clinical trials
Authors' conclusion
A risk-based approach to adjudication can potentially allow compromise between costs and accuracy.
Study context
- Population
- Major cardiovascular randomized controlled trials (RCTs) reporting both adjudicated and non-adjudicated endpoints
- Comparison
- Adjudicated vs non-adjudicated site-designated endpoints
Main finding
As reported in the abstract
- Endpoint adjudication (EA) value likely greater with nuanced primary endpoints, definitions poorly aligned with practice, sub-optimal data completeness, greater operator variability and lack of blinding
- EA may not be needed if primary endpoint is all-cause death or all-cause hospitalization
- EA likely merited for MI, bleeding, worsening HF as outpatient, unstable angina or TIA
Original publication
Endpoint adjudication in cardiovascular clinical trials. Eur Heart J. Published 3 November 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →