R-TPI: rolling toxicity probability interval design to shorten the duration and maintain safety of phase I trials

References

• Ananthakrishnan, R., S. Green, M. Chang, G. Doros, J. Massaro, and M. LaValley. 2017. Systematic comparison of the statistical operating characteristics of various phase I oncology designs. Contemporary Clinical Trials Communications 5:34–48. doi:10.1016/j.conctc.2016.11.006.
   PubMed Web of Science ®Google Scholar
• Broglio, K. R., L. Sandalic, T. Albertson, and S. M. Berry. 2015. Bayesian dose escalation in oncology with sharing of information between patient populations. Contemporary Clinical Trials 44:56–63. doi:10.1016/j.cct.2015.07.003.
   PubMed Web of Science ®Google Scholar
• Cheung, Y. K., and R. Chappell. 2000. Sequential designs for phase I clinical trials with late-onset toxicities. Biometrics 56 (4):1177–1182. doi:10.1111/j.0006-341X.2000.01177.x.
   PubMed Web of Science ®Google Scholar
• Doussau, A., B. Geoerger, I. Jiménez, and X. Paoletti. 2016. Innovations for phase I dose-finding designs in pediatric oncology clinical trials. Contemporary Clinical Trials 47:217–227. doi:10.1016/j.cct.2016.01.009.
   PubMed Web of Science ®Google Scholar
• Good, I. J. 1967. A bayesian significance test for multinomial distributions. Journal Of The Royal Statistical Society. Series B (Methodological) 29:399–431. doi:10.1111/rssb.1967.29.issue-3.
   Web of Science ®Google Scholar
• Guo, W., S.-J. Wang, S. Yang, H. Lynn, and Y. Ji. 2017. A Bayesian interval dose-finding design addressing Ockham’s razor: Mtpi-2. Contemporary Clinical Trials 58:23–33. doi:10.1016/j.cct.2017.04.006.
   PubMed Web of Science ®Google Scholar
• Ivanova, A., and K. Wang. 2006. Bivariate isotonic design for dose-finding with ordered groups. Statistics in Medicine 25 (12):2018–2026. doi:10.1002/(ISSN)1097-0258.
   PubMed Web of Science ®Google Scholar
• Jefferys, W. H., and J. O. Berger. 1992. Ockham’s razor and Bayesian analysis. American Scientist 80 (1):64–72.
   Web of Science ®Google Scholar
• Ji, Y., P. Liu, Y. Li, and B. Nebiyou Bekele. 2010. A modified toxicity probability interval method for dose-finding trials. Clinical Trials 7 (6):653–663. doi:10.1177/1740774510382799.
   PubMed Web of Science ®Google Scholar
• Ji, Y., and S. Yang. 2017. On the interval-based dose-finding designs. ArXiv 1706.03277 [stat.ME].
   Google Scholar
• Ji, Y., and S.-J. Wang. 2013. Modified toxicity probability interval design: A safer and more reliable method than the 3+ 3 design for practical phase I trials. Journal of Clinical Oncology 31 (14):1785. doi:10.1200/JCO.2013.49.0219.
   PubMed Web of Science ®Google Scholar
• Lee, D. P., J. M. Skolnik, and P. C. Adamson. 2005. Pediatric phase I trials in oncology: An analysis of study conduct efficiency. Journal of Clinical Oncology 23 (33):8431–8441. doi:10.1200/JCO.2005.02.1568.
   PubMed Web of Science ®Google Scholar
• Onar-Thomas, A., and Z. Xiong. 2010. A simulation-based comparison of the traditional method, rolling-6 design and a frequentist version of the continual reassessment method with special attention to trial duration in pediatric phase I oncology trials. Contemporary Clinical Trials 31 (3):259–270. doi:10.1016/j.cct.2010.03.006.
   PubMed Web of Science ®Google Scholar
• Skolnik, J. M., J. S. Barrett, B. Jayaraman, D. Patel, and P. C. Adamson. 2008. Shortening the timeline of pediatric phase I trials: The rolling six design. Journal of Clinical Oncology 26 (2):190–195. doi:10.1200/JCO.2007.15.2777.
   PubMed Web of Science ®Google Scholar
• Sposto, R., and S. Groshen. 2011. A wide-spectrum paired comparison of the properties of the rolling 6 and 3+ 3 phase I study designs. Contemporary Clinical Trials 32 (5):694–703. doi:10.1016/j.cct.2011.04.009.
   PubMed Web of Science ®Google Scholar
• Thorburn, W. M. 1918. The myth of Occam’s razor. Mind 27 (107):345–353. doi:10.1093/mind/XXVII.3.345.
   Google Scholar
• Yuan, Y., R. Lin, D. Li, L. Nie, and K. E. Warren. 2018. Time-to-event Bayesian optimal interval design to accelerate phase I trials. Clinical Cancer Research clincanres–0246.
   PubMed Web of Science ®Google Scholar
• Zhao, L., J. Lee, R. Mody, and T. M. Braun. 2011. The superiority of the time-to-event continual reassessment method to the rolling six design in pediatric oncology phase I trials. Clinical Trials 8 (4):361–369. doi:10.1177/1740774511407533.
   PubMed Web of Science ®Google Scholar
• Zhou, H., Y. Yuan, and L. Nie. 2018. Accuracy, safety, and reliability of novel phase I trial designs. Clinical Cancer Research clincanres–0168.
   PubMed Web of Science ®Google Scholar