A system for determining maximum tolerated dose in clinical trial

ISSN 2475-4269

CN 31-2182/O1

Xiaobin Yang ,

HouseCanary Inc., San Antonio, TX, USA

Ying Ji ,

University of Texas at San Antonio, San Antonio, TX, USA

Min Wang

University of Texas at San Antonio, San Antonio, TX, USA

Pages 288-302 | Received 21 Jan. 2020, Accepted 01 Jan. 2021, Published online: 20 Jan. 2021,

Abstract
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Toxicity study, especially in determining the maximum tolerated dose (MTD) in phase I clinical trial, is an important step in developing new life-saving drugs. In practice, toxicity levels may be categorised as binary grades, multiple grades, or in a more generalised case, continuous grades. In this study, we propose an overall MTD framework that includes all the aforementioned cases for a single toxicity outcome (response). The mechanism of determining MTD involves a function that is predetermined by user. Analytic properties of such a system are investigated and simulation studies are performed for various scenarios. The concept of the continual reassessment method (CRM) is also implied in the framework and Bayesian analysis, including Markov chain Monte Carlo (MCMC) methods are used in estimating the model parameters.

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To cite this article: Keying Ye, Xiaobin Yang, Ying Ji & Min Wang (2021) A system for determining maximum tolerated dose in clinical trial, Statistical Theory and Related Fields, 5:4, 288-302, DOI:10.1080/24754269.2021.1871708
To link to this article: https://doi.org/10.1080/24754269.2021.1871708

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