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Dose-Finding Based on Bivariate Efficacy-Toxicity Outcome Using Archimedean Copula

Author

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  • Yuxi Tao
  • Junlin Liu
  • Zhihui Li
  • Jinguan Lin
  • Tao Lu
  • Fangrong Yan

Abstract

In dose-finding clinical study, it is common that multiple endpoints are of interest. For instance, efficacy and toxicity endpoints are both primary in clinical trials. In this article, we propose a joint model for correlated efficacy-toxicity outcome constructed with Archimedean Copula, and extend the continual reassessment method (CRM) to a bivariate trial design in which the optimal dose for phase III is based on both efficacy and toxicity. Specially, considering numerous cases that continuous and discrete outcomes are observed in drug study, we will extend our joint model to mixed correlated outcomes. We demonstrate through simulations that our algorithm based on Archimedean Copula model has excellent operating characteristics.

Suggested Citation

  • Yuxi Tao & Junlin Liu & Zhihui Li & Jinguan Lin & Tao Lu & Fangrong Yan, 2013. "Dose-Finding Based on Bivariate Efficacy-Toxicity Outcome Using Archimedean Copula," PLOS ONE, Public Library of Science, vol. 8(11), pages 1-6, November.
    • Handle: RePEc:plo:pone00:0078805
    DOI: 10.1371/journal.pone.0078805
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    References listed on IDEAS

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    1. Peter F. Thall & John D. Cook, 2004. "Dose-Finding Based on Efficacy–Toxicity Trade-Offs," Biometrics, The International Biometric Society, vol. 60(3), pages 684-693, September.
    2. Guosheng Yin & Yisheng Li & Yuan Ji, 2006. "Bayesian Dose-Finding in Phase I/II Clinical Trials Using Toxicity and Efficacy Odds Ratios," Biometrics, The International Biometric Society, vol. 62(3), pages 777-787, September.
    3. John O'Quigley & Michael D. Hughes & Terry Fenton, 2001. "Dose-Finding Designs for HIV Studies," Biometrics, The International Biometric Society, vol. 57(4), pages 1018-1029, December.
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    1. S. G. J. Senarathne & C. C. Drovandi & J. M. McGree, 2020. "Bayesian sequential design for Copula models," TEST: An Official Journal of the Spanish Society of Statistics and Operations Research, Springer;Sociedad de Estadística e Investigación Operativa, vol. 29(2), pages 454-478, June.
    2. I. E. Okorie & A. C. Akpanta & J. Ohakwe & D. C. Chikezie & C. U. Onyemachi & M. C. Ugwu, 2021. "Modeling the Relationships Across Nigeria Inflation, Exchange Rate, and Stock Market Returns and Further Analysis," Annals of Data Science, Springer, vol. 8(2), pages 295-329, June.
    3. Laura Deldossi & Silvia Angela Osmetti & Chiara Tommasi, 2019. "Optimal design to discriminate between rival copula models for a bivariate binary response," TEST: An Official Journal of the Spanish Society of Statistics and Operations Research, Springer;Sociedad de Estadística e Investigación Operativa, vol. 28(1), pages 147-165, March.

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