A modified Huber loss function for continual reassessment methods in clinical trials

REFERENCES

• Abbruzzese, J. L., R. Grunewald, E. A. Weeks, D. Gravel, T. Adams, B. Nowak, S. Mineishi, P. Tarassoff, W. Satterlee, and M. N. Raber. 1991. “A Phase I Clinical, Plasma, and Cellular Pharmacology Study of Gemcitabine.” Journal of Clinical Oncology 9 (3): 491–498. https://doi.org/10.1200/JCO.1991.9.3.491
   PubMed Web of Science ®Google Scholar
• Ananthakrishnan, R., R. Lin, C. He, Y. Chen, D. Daniel Li, and M. LaValley. 2022. “An Overview of the BOIN Design and Its Current Extensions for Novel Early-Phase Oncology Trials.” Contemporary Clinical Trials Communications 28 (2022): 100943. https://doi.org/10.1016/j.conctc.2022.100943
   PubMedGoogle Scholar
• Araujo, D. V., M. Oliva, K. Li, R. Fazelzad, Z. A. Liu, and L. L. Siu. 2021. “Contemporary Dose-Escalation Methods for Early Phase Studies in the Immunotherapeutics Era.” European Journal of Cancer 158: 85–98. https://doi.org/10.1016/j.ejca.2021.09.016
   PubMed Web of Science ®Google Scholar
• Babb, J. S., and A. Rogatko. 2001. “Patient Specific Dosing in a Cancer Phase I Clinical Trial.” Statistics in Medicine 20 (14): 2079–2090. https://doi.org/10.1002/sim.848
   PubMed Web of Science ®Google Scholar
• Bellman, R. 1952. “On the Theory of Dynamic Programming.” Proceedings of the National Academy of Sciences of the United States of America 38 (8): 716–719. https://doi.org/10.1073/pnas.38.8.716
   PubMed Web of Science ®Google Scholar
• Berry, S. M., B. P. Carlin, J. J. Lee, and P. Muller. 2010. Bayesian Adaptive Methods for Clinical Trials. Boca Raton, FL: CRC Press.
   Google Scholar
• Carter, S. K. 1972. “Study Design Principles for the Clinical Evaluation of New Drugs as Developed by the Chemotherapy Program of the National Cancer Institute.” In The Design of Clinical Trials in Cancer Therapy, edited by M. Staquet, 242–289. Bruxelles: Sc. Europ.
   Google Scholar
• Cheung, Y. K. 2011. Dose Finding by the Continual Reassessment Method. London, UK: CRC Press.
   Google Scholar
• Flournoy, N., and A. P. Oron. 2020. “Bias Induced by Adaptive Dose-Finding Designs.” Journal of Applied Statistics 47 (13-15): 2431–2442. https://doi.org/10.1080/02664763.2019.1649375
   PubMed Web of Science ®Google Scholar
• Ghosh, B. K., and P. K. Sen. 1991. Handbook of Sequential Analysis. New York: Dekker.
   Google Scholar
• Heyd, J. M., and B. P. Carlin. 1999. “Adaptive Design Improvements in the Continual Reassessment Method for Phase I Studies.” Statistics in Medicine 18 (11): 1307–1321. https://doi.org/10.1002/(SICI)1097-0258(19990615)18:11<1307::AID-SIM128>3.0.CO;2-X
   PubMed Web of Science ®Google Scholar
• Hill, S. D., and J. C. Spall. 2019. “Stationarity and Convergence of the Metropolis-Hastings Algorithm: Insights into Theoretical Aspects.” IEEE Control Systems 39 (1): 56–67. https://doi.org/10.1109/MCS.2018.2876959
   Web of Science ®Google Scholar
• Huber, P. J. 1964. “Robust Estimation of a Location Parameter.” The Annals of Mathematical Statistics 35 (1): 73–101. https://doi.org/10.1214/aoms/1177703732
   Google Scholar
• Ishizuka, N., and Y. Ohashi. 2001. “The Continual Reassessment Method and Its Applications: A Bayesian Methodology for Phase I Cancer Clinical Trials.” Statistics in Medicine 20 (17-18): 2661–2681. https://doi.org/10.1002/sim.735
   PubMed Web of Science ®Google Scholar
• Ji, Y., Y. Li, and B. N. Bekele. 2007. “Dose-Finding in Phase I Clinical Trials Based on Toxicity Probability Intervals.” Clinical Trials (London, England) 4 (3): 235–244. https://doi.org/10.1177/1740774507079442
   PubMed Web of Science ®Google Scholar
• Korn, E. L., D. Midthune, T. T. Chen, L. V. Rubinstein, M. C. Christian, and R. M. Simon. 1994. “A Comparison of Two Phase I Trial Designs.” Statistics in Medicine 13 (18): 1799–1806. https://doi.org/10.1002/sim.4780131802
   PubMed Web of Science ®Google Scholar
• Le Tourneau, C., J. J. Lee, and L. L. Siu. 2009. “Dose Escalation Methods in Phase I Cancer Clinical Trials.” Journal of the National Cancer Institute 101 (10): 708–720. https://doi.org/10.1093/jnci/djp079
   PubMedGoogle Scholar
• Lee, S. M., and Y. K. Cheung. 2009. “Model Calibration in the Continual Reassessment Method.” Clinical Trials 6 (3): 227–238. https://doi.org/10.1177/1740774509105076
   PubMed Web of Science ®Google Scholar
• Lee, S. M., and Y. K. Cheung. 2011. “Calibration of Prior Variance in the Bayesian Continual Reassessment Method.” Statistics in Medicine 30 (17): 2081–2089. https://doi.org/10.1002/sim.4139
   PubMed Web of Science ®Google Scholar
• Liu, S., and Y. Yuan. 2015. “Bayesian Optimal Interval Designs for Phase I Clinical Trials.” Journal of the Royal Statistical Society: Series C (Applied Statistics) 64 (3): 507–523. https://doi.org/10.1111/rssc.12089
   Web of Science ®Google Scholar
• Neuenschwander, B., M. Branson, and T. Gsponer. 2008. “Critical Aspects of the Bayesian Approach to Phase I Cancer Trials.” Statistics in Medicine 27 (13): 2420–2439. https://doi.org/10.1002/sim.3230
   PubMed Web of Science ®Google Scholar
• O’Quigley, J., M. Pepe, and L. Fisher. 1990. “Continual Reassessment Method: A Practical Design for Phase 1 Clinical Trials in Cancer.” Biometrics 46 (1): 33–48. https://doi.org/10.2307/2531628
   PubMed Web of Science ®Google Scholar
• O’Quigley, J., and S. Zohar. 2006. “Experimental Designs for Phase I and Phase I/II Dose-Finding Studies.” British Journal of Cancer 94 (5): 609–613. https://doi.org/10.1038/sj.bjc.6602969
   PubMed Web of Science ®Google Scholar
• Paoletti, X., and A. Kramar. 2009. “A Comparison of Model Choices for the Continual Reassessment Method in Phase I Cancer Trials.” Statistics in Medicine 28 (24): 3012–3028. https://doi.org/10.1002/sim.3682
   PubMed Web of Science ®Google Scholar
• Paoletti, X., J. O’Quigley, and J. Maccario. 2004. “Design Efficiency in Dose Finding Studies.” Computational Statistics & Data Analysis 45 (2): 197–214. https://doi.org/10.1016/S0167-9473(02)00323-7
   Web of Science ®Google Scholar
• Piantadosi, S., and J. Fisher, and S. Grossman. 1998. “Practical Implementation of a Modified Continual Reassessment Method for Dose-Finding Trials.” Cancer Chemotherapy and Pharmacology 41 (6): 429–436. https://doi.org/10.1007/s002800050763
   PubMed Web of Science ®Google Scholar
• Siegmund, D. 1985. Sequential Analysis. New York: Springer.
   Google Scholar
• Storer, B. E. 1989. “Design and Analysis of Phase I Clinical Trials.” Biometrics 45 (3): 925–937.
   PubMed Web of Science ®Google Scholar
• Sweeting, M., and A. Mander, and T. Sabin. 2013. “bcrm: Bayesian Continual Reassessment Method Designs for Phase I Dose-Finding Trials.” Journal of Statistical Software 54 (13): 1–26. https://doi.org/10.18637/jss.v054.i13
   Web of Science ®Google Scholar
• Thomas, A., B. O’Hara, U. Ligges, and S. Sturtz. 2006. “Making BUGS Open.” R News 6 (1): 12–17.
   Google Scholar
• Woodroofe, M. 1982. Nonlinear Renewal Theory in Sequential Analysis. Philadelphia: SIAM.
   Google Scholar