A Bayesian Sequential Design for Clinical Trials with Time-to-Event Outcomes

There is increasing interest in Bayesian group sequential design because of its potential to improve efficiency in clinical trials, to shorten drug development time, and to enhance statistical inference precision without undermining the clinical trial’s integrity or validity. We propose a Bayesian sequential design for clinical trials with time-to-event outcomes and use alpha spending functions to control the overall type I error rate. Bayes factor is adapted for decision-making at interim analyses. Algorithms are presented to make decision rules and to calculate power of the proposed tests. Sensitivity analysis is implemented to evaluate the impact of different choices of prior parameters on choosing critical values. The power of tests, the expected event size of the proposed design, and the quality of estimators are studied through simulations, and compared with the frequentist group sequential design. Simulations show that at fixed total number of events, the proposed design can achieve greater power and require smaller expected event size when appropriate priors are chosen, compared with the frequentist group sequential design. The feasibility of the proposed design is further illustrated on a real data set.

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PID https://www.doi.org/10.6084/m9.figshare.8326613.v1
URL http://dx.doi.org/10.6084/m9.figshare.8326613.v1
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Author Zhu, Lin
Author Qingzhao Yu
Author Mercante, Donald E.
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Collected From Datacite
Hosted By figshare
Publication Date 2019-01-01
Publisher Taylor & Francis
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Language UNKNOWN
Resource Type Other ORP type
keyword FOS: Mathematics
system:type other
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Source https://science-innovation-policy.openaire.eu/search/other?orpId=datacite____::be084384e70e874e0e40a339204664b8
Author jsonws_user
Last Updated 20 December 2020, 03:38 (CET)
Created 20 December 2020, 03:38 (CET)