An approach to use of an adaptive procedure to clinical trials for molecularly heterogenous subject selection at interim

Feng-shou Ko

Communications in Statistics - Theory and Methods, 2020, vol. 49, issue 2, 421-429

Abstract: For clinical trials, molecular heterogeneity has played a more important role recently. Many novel clinical trial designs prospectively incorporate molecular information to evaluation of treatment effects. In this paper, an adaptive procedure incorporating a non-pre-specified genomic biomarker is employed in the interim of a conventional trial. A non-pre-specified binary genomic biomarker, which is predictive of treatment effect, is used to classify study patients into two mutually exclusive subgroups at the interim review. According to the observations at the interim stage, adaptations such as adjusting sample size or shifting eligibility of study patients are then made in case of different scenarios.

Date: 2020
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Persistent link: https://EconPapers.repec.org/RePEc:taf:lstaxx:v:49:y:2020:i:2:p:421-429

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DOI: 10.1080/03610926.2018.1543770

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