Quantifying the bias in the estimated treatment effect in randomized trials having interim analyses and a rule for early stopping for futility.
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DOI: 10.1002/sim.7242
Abstract: In this paper, we consider the potential bias in the estimated treatment effect obtained from clinical trials, the protocols of which include the possibility of interim analyses and an early termination of the study for… read more here.
Keywords: futility; treatment; interim analyses; bias ... See more keywords
REDUCE-IT: accumulation of data across prespecified interim analyses to final results
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DOI: 10.1093/ehjci/ehaa946.3010
Abstract: REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial), an event-driven trial, randomized 8,179 statin-treated patients with elevated triglycerides (TGs) and increased cardiovascular (CV) risk to icosapent ethyl (IPE); pure, stable prescription eicosapentaenoic acid, 4g/day… read more here.
Keywords: across prespecified; endpoint; safety; efficacy ... See more keywords