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PLOS ONE  2013 

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

DOI: 10.1371/journal.pone.0078805

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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.

References

[1]  Bornkamp B, Bretz F, Dmitrienko A, Enas G, Gaydos B, et al. (2007) Innovative approaches for designing and analyzing adaptive dose-ranging trials. Journal of biopharmaceutical statistics 17: 965–995.
[2]  Chevret S, Wiley J (2006) Statistical methods for dose-finding experiments: John Wiley and Sons Limited.
[3]  Ting N (2006) Dose finding in drug development:Springer.
[4]  Thall PF, Cook JD (2004) Dose-finding based on efficacy–toxicity trade-offs. Biometrics 60: 684–693.
[5]  Yin G, Li Y, Ji Y (2006) Bayesian dose-finding in Phase I/II clinical trials using toxicity and efficacy odds ratios. Biometrics 62: 777–787.
[6]  O’Quigley J, Hughes MD, Fenton T (2001) Dose-finding designs for HIV studies. Biometrics 57: 1018–1029.
[7]  Thall PF, Russell KE (1998) A strategy for dose-finding and safety monitoring based on efficacy and adverse outcomes in phase I/II clinical trials. Biometrics 54: 251–264.
[8]  Zhang W, Sargent DJ, Mandrekar S (2006) An adaptive dose-finding design incorporating both toxicity and efficacy. Statistics in Medicine 25: 2365–2383.
[9]  Braun TM (2002) The bivariate continual reassessment method. extending the CRM to phase I trials of two competing outcomes. Controlled Clinical Trials 23: 240–256.
[10]  Dragalin V, Fedorov V (2006) Adaptive designs for dose-finding based on efficacy–toxicity response. Journal of Statistical Planning and Inference 136: 1800–1823.
[11]  Fedorov VV, Wu Y (2007) Dose finding designs for continuous responses and binary utility. Journal of biopharmaceutical statistics 17: 1085–1096.
[12]  Fedorov V, Wu Y, Zhang R (2012) Optimal dose-finding designs with correlated continuous and discrete responses. Statistics in Medicine 31: 217–234.
[13]  Dragalin V, Fedorov VV, Wu Y (2008) Two-stage design for dose-finding that accounts for both efficacy and safety. Statistics in Medicine 27: 5156–5176.
[14]  TAO A (2010) A dose finding method in joint modeling of efficacy and safety : Rutgers, The State University of New Jersey.
[15]  O’Quigley J, Pepe M, Fisher L (1990) Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics 46: 33–48.
[16]  Ishizuka N, Ohashi Y (2001) The continual reassessment method and its applications: a Bayesian methodology for phase I cancer clinical trials. Statistics in Medicine 20: 2661–2681.
[17]  O’Quigley J, Conaway M (2010) Continual reassessment and related dose-finding designs.Statistical science: a review journal of the Institute of Mathematical Statistics. 25: 202–216.
[18]  Lee SM, Cheng B, Cheung YK (2011) Continual reassessment method with multiple toxicity constraints. Biostatistics 12: 386–398.
[19]  Fréchet M (1951) Sur les tableaux de corrélation dont les marges sont données. Annales de I’Université de Lyon.Section A: Sciences mathématiques et astronomie 9: 53–77.
[20]  Sklar A (1959) Fonctions de répartition à n dimensions et leurs marges.Publications de l’Institut de Statistique de l’Université de Paris. 8: 229–231.
[21]  Ruberg SJ (1995) Dose response studies I. Some design considerations. Journal of Biopharmaceutical Statisties 5: 1–14.
[22]  Nebiyou Bekele B, Shen Y (2005) A bayesian approach to jointly modeling toxicity and biomarker expression in a Phase I/II dose-finding trial. Biometrics 61: 343–354.
[23]  Manner H (2007) Estimation and model selection of copulas with an application to exchange rates: Maastricht Research School of Economics of Technology and Organizations.

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