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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

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  • Xiaobin Yang

    (University of Texas at San Antonio)

  • Keying Ye

    (University of Texas at San Antonio)

Abstract

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  • Xiaobin Yang & Keying Ye, 2012. "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 c," Working Papers 0004, College of Business, University of Texas at San Antonio.
    • Handle: RePEc:tsa:wpaper:0016mss
    as

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    File URL: http://interim.business.utsa.edu/wps/mss/0004MSS-432-2012.pdf
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    References listed on IDEAS

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    1. Z. Yuan & R. Chappell & H. Bailey, 2007. "The Continual Reassessment Method for Multiple Toxicity Grades: A Bayesian Quasi-Likelihood Approach," Biometrics, The International Biometric Society, vol. 63(1), pages 173-179, March.
    2. Xiaobin Yang & Keying Ye & Yanping Wang, 2011. "A Study of the Probit Model with Latent Variables in Phase I Clinical Trials," Working Papers 0030, College of Business, University of Texas at San Antonio.
    3. Bekele, B. Nebiyou & Thall, Peter F., 2004. "Dose-Finding Based on Multiple Toxicities in a Soft Tissue Sarcoma Trial," Journal of the American Statistical Association, American Statistical Association, vol. 99, pages 26-35, January.
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