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Activity Number: 441 - Bayesian (and Other) Clinical Trials Designs
Type: Contributed
Date/Time: Thursday, August 12, 2021 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract #317767
Title: Operational Characteristics of Generalized Pairwise Comparisons for Hierarchically Ordered Endpoints
Author(s): Vaiva Deltuvaite-Thomas* and Tomasz Burzykowski
Companies: IDDI and IDDI
Keywords: clinical trials; hierarchical endpoints; generalized pairwise comparisons; net benefit; statistical power; type-I error probability
Abstract:

The method of generalized pairwise comparisons (GPC) allows comparing two groups of observations based on multiple hierarchically-ordered endpoints, regardless of their number or type. The summary measure, ``net benefit'', quantifies the difference between the probabilities that a random observation from one group is ``better'' than an observation from the opposite group. The method takes into account the correlations between the endpoints. We have performed a simulation study for the case of two endpoints to evaluate the impact of the correlation on the type-I error probability and power of the test based on GPC. The simulations show that the overall power of the hierarchical GPC procedure depends, in a complex manner, on the entire variance-covariance structure of the set of outcomes. The change in power when the secondary endpoint is included in the GPC analysis depends on the correlation between the endpoints. Interestingly, a decrease in power can occur regardless of whether there is any marginal treatment effect on the secondary endpoint. Anticipating correlations between the outcomes might be challenging when designing a trial based on the hierarchical GPC procedure.


Authors who are presenting talks have a * after their name.

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