A Phase I Dose-_finding Study Based on Polychotomous Toxicity Responses Toxicity issue is always a main concern in phase I study and it is commonly categorized to multiple grades. In this study, the concept of overall maximum tolerated dose (overall MTD) is introduced along with its analytic properties. The traditional definition of MTD is shown to be a special case of the overall MTD. A dose finding strategy is also proposed to find the overall MTD. Motivated by the continual reassessment method (CRM), a cumulative probit model with latent variables is introduced to fit the data. By introducing latent variables, Markov chain Monte Carlo (MCMC) methods are employed to estimate the model parameters. Simulation studies show that the cumulative probit model, which takes into account of the severity level of toxicity, reduces the number of patients allocated to the higher toxicity dose level. This could reduce the risk of toxicity for patients in the phase I study

Yang, Xiaobin; Ye, Keying

A Phase I Dose-_finding Study Based on Polychotomous Toxicity Responses Toxicity issue is always a main concern in phase I study and it is commonly categorized to multiple grades. In this study, the concept of overall maximum tolerated dose (overall MTD) is introduced along with its analytic properties. The traditional definition of MTD is shown to be a special case of the overall MTD. A dose finding strategy is also proposed to find the overall MTD. Motivated by the continual reassessment method (CRM), a cumulative probit model with latent variables is introduced to fit the data. By introducing latent variables, Markov chain Monte Carlo (MCMC) methods are employed to estimate the model parameters. Simulation studies show that the cumulative probit model, which takes into account of the severity level of toxicity, reduces the number of patients allocated to the higher toxicity dose level. This could reduce the risk of toxicity for patients in the phase I study

Xiaobin Yang and Keying Ye
Additional contact information
Xiaobin Yang: University of Texas at San Antonio
Keying Ye: University of Texas at San Antonio

No 4, Working Papers from College of Business, University of Texas at San Antonio

Keywords: phase I clinical trial; polychotomous toxicity responses; dose finding; continual reassessment method (CRM); cumulative probit model; latent variable; Markov chain Monte Carlo (MCMC) (search for similar items in EconPapers)
Pages: 22 pages
Date: 2012-02-21
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