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Activity Number:
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77
- Contributed Poster Presentations: Biopharmaceutical Section
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2020 : 10:00 AM to 2:00 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #312775
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Title:
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Bayesian Design of Clinical Trials for Joint Models of Recurrent Event with a Terminating Event
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Author(s):
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Jiawei Xu* and Matthew A. Psioda and Joseph G. Ibrahim
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Companies:
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UNC Chapel Hill and University of North Carolina and University of North Carolina at Chapel Hill
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Keywords:
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Bayesian design;
Clinical trials;
Joint models
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Abstract:
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Joint models are increasingly used for the analysis of clinical trials data, like recurrent and terminating event data. However, few methods have been proposed for designing clinical trials using these models. We propose an approach for clinical design of recurrent and terminating event processes. We focus on estimating the treatment's effect using a general joint frailty model based on gap times. A superiority test is proposed to jointly test the treatment's effect while both recurrent and terminating events are treated as primary endpoints. A sample size determination procedure is developed such that the design has a relatively high power and a well-controlled type I error rate, with both operating characteristics defined from a Bayesian perspective. A colorectal cancer clinical trial with readmission times to hospital after surgery as the recurrent event and death event will be used to demonstrate the proposed methodology.
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Authors who are presenting talks have a * after their name.
