Communications for Statistical Applications and Methods

The Korean Statistical Society (한국통계학회)
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Maximum Tolerated Dose Estimation Applied Biased Coin Design in a Phase I Clinical Trial

  • Kim, Yu Rim (Department of Biostatistics, The Catholic University of Korea) ;
  • Kim, Dongjae (Department of Biostatistics, The Catholic University of Korea)
  • Received : 2012.08.14
  • Accepted : 2012.10.09
  • Published : 2012.11.30
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Abstract

Phase I trials determine the maximum tolerated dose(MTD) and the recommended dose(RD) for subsequent Phase II trials. In this paper, a MTD estimation method applied to a biased coin design is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the SM3 method and the NM method (Lee and Kim, 2012) using a Monte Carlo simulation study.

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References

  1. Ahn, C. (1998). An evaluation of phase I cancer clinical trial designs, Statistics in Medicine, 17, 1537- 1549. https://doi.org/10.1002/(SICI)1097-0258(19980730)17:14<1537::AID-SIM872>3.0.CO;2-F
  2. Antognini, A. B. and Giovagnoli, A. (2004). A new "biased coin design" for the sequential allocation of two treatments, Italian Statistical Society.
  3. Chevret, S. (1993). The continual reassessment method in cancer phase I clinical trials: A simulation study, Statistics in Medicine, 12, 1093-1108. https://doi.org/10.1002/sim.4780121201
  4. Dixon, W. J. and Mood, A. M. (1948). A method for obtaining and analyzing sensitivity data, Journal of the American Statistical Association, 43, 109-126. https://doi.org/10.1080/01621459.1948.10483254
  5. Goodman, S. N., Zhurak, M. L. and Piantadosi, S. (1995). Some practical improvements in the continual reassessment method for Phase I studies, Statistics in Medicine, 14, 1149-1161. https://doi.org/10.1002/sim.4780141102
  6. Kang, S. H. (2002). Investigation on the modified continual reassessment method in phase I clinical trial, Journal of Applied Statistics, 15, 323-336. https://doi.org/10.5351/KJAS.2002.15.2.323
  7. Korn, E. L., Midthune, D., Chen, T. T., Rubinstein, L. V., Christian, M. C. and Simon, R. M. (1994). A comparison of two phase I trial designs, Statistics in Medicine, 13, 1799-1806. https://doi.org/10.1002/sim.4780131802
  8. Lee, N. M. and Kim, D. (2012). Two-stage maximum tolerated dose estimation by stopping rule in a phase I clinical trial, Communications of the Korean Statistical Society.
  9. O'Quigley, J. and Chevret, S. (1991). Method for dose finding studies in cancer clinical trials: A review and results of a Monte Carlo study, Statistics in Medicine, 10, 1647-1664. https://doi.org/10.1002/sim.4780101104
  10. O'Quigley, J., Pepe, M. and Fisher, M. (1990). Continual reassessment method: A practical design for phase I clinical trials in cancer, Biometrics, 46, 33-48. https://doi.org/10.2307/2531628
  11. O'Quigley, J. and Shen, L. Z. (1996). Continual reassessment method: A likelihood approach, Biometrics, 52, 163-174.
  12. Park, I. H. (1999). The estimation of maximal tolerated dose in sequential phase I clinical trials, Department of Biostatistics, The Catholic University of Korea, Biostatistics Master's Thesis.
  13. Storer, B. E. (1989). Design and analysis of phase I clinical trials, Biometrics, 45, 925-937. https://doi.org/10.2307/2531693