Journal of Korean Society for Quality Management (품질경영학회지)

Korean Society for Quality Management (한국품질경영학회)
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Effect of the Erimental Design on the Determination of MTD in Phase I Clinical Trial

약물독성시험에서 실험설계가 MTD의 결정에 미치는 영향

  • Received : 2011.05.13
  • Accepted : 2011.06.15
  • Published : 2011.06.30
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Abstract

The purpose of Phase I clinical trial is to identify the maximum tolerated dose with specific toxicity rate. The standard TER design does not guarantee the pre-specified toxicity rate. It depends on the dose-toxicity curves. Therefore it is necessary to check the expected toxicity rate of various dose-toxicity curves before we conduct clinical trials. We developed TERAplusB library to help this situation, especially in cancer research. This package will help design the cancer clinical trial. We can compare the expected toxicity rates, the expected number of patients, and the expected times calculated with various dose-toxicity curves. This process will help find the best clinical trial design of the proposed drug.

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References

  1. 강승호 (2002). "1상 임상실험에서 수정된 CRM에 대한 연구", 응용통계연구, 15권 2호, pp323-336.
  2. 김동욱, 길순경 (2009). "제 1상 임상시험의 SM, CRM, ATD에서 결정된 MTD의 정확성과 안전성 비교", 한국통계학회논문집, 16권 1호, pp51-65.
  3. Ahn, C. (1998). "An evaluation of phase I cancer clinical trial designs", Statistics in medicine, Vol. 17, pp1537-1549. https://doi.org/10.1002/(SICI)1097-0258(19980730)17:14<1537::AID-SIM872>3.0.CO;2-F
  4. Chow S-C., and Chang M. (2007). Adaptive Design Methods in Clinical Trials, Chapman and Hall /CRC.
  5. Dragalin, V., and Fedorov, V.(2006). "Adaptive designs for dose-finding based on efficacy-toxicity response", Journal of Statistical Planning and Inference, Vol. 136, pp1800-1823. https://doi.org/10.1016/j.jspi.2005.08.005
  6. Edler, L.(1990). "Statistical Requirements of Phase I Studies", Onkelogie, Vol. 13, pp90-95. https://doi.org/10.1159/000216733
  7. Gezmu, M., and Flournoy, N. (2006). "Group up-anddown designs for dose-finding", Journal of Statistical Planning and Inference, Vol. 136, pp1749-1764. https://doi.org/10.1016/j.jspi.2005.08.002
  8. Ivanova, A. and Wang, K. (2006). "Bivariate isotonic design for dose-finding with ordered groups", Statistics in medicine, Vol. 25, pp2018-2026. https://doi.org/10.1002/sim.2312
  9. Kang, S-H., Ahn, C. (2001). "The expected toxicity rate at the maximum tolerated dose in the standard phase I cancer clinical trial design", Drug Information Journal, Vol. 35, pp1189-1199. https://doi.org/10.1177/009286150103500416
  10. Lin Y., and Shih, W. J.(2001). "Statistical properties of the traditional algorithm-based designs for phase I cancer clinical trials", Biostatistics, Vol. 2 No.2, pp203-215.
  11. Mahajan, R., and Gupta, K. (2011). "Adaptive design clinical trials : Methodology, challenges and prospect", Indian Journal of Pharmacology, Vol. 42 No.4 pp 201-207.
  12. Simon, R., Freidlin, B., Rubinstein, L., Arbuck, S.G., Collins, J. and Christian, M. C.(1997). "Accelerated Titration Designs for Phase I Clinical Trials in Oncology", Journal of national Cancer Institute, Vol.89 No. 15, pp1138-1147. https://doi.org/10.1093/jnci/89.15.1138
  13. Storer, B. E.(1989). "Design and Analysis of Phase I Clinical Trials", Biometrics, Vol. 45, pp925-937. https://doi.org/10.2307/2531693
  14. Ting, N. (2006). Dose findings in drug development, Springer NY
  15. Tourneau, C. L, Lee, J. J. and siu L. L.(2009). "Dose Escalation Methods in Phase I cancer Clinical Trials", Journal of National Cancer Institute, Vol. 101 No.10, pp708-720. https://doi.org/10.1093/jnci/djp079