<abstract xmlns="http://www.w3.org/1999/xhtml"><p>The continual reassessment method is a model-based procedure, described in the literature, used to determine the maximum tolerated dose in phase I clinical trials. The maximum tolerated dose can also be found under the framework of <italic>D</italic>-optimum design, where information is gathered in such a way so that asymptotic variability in the parameter estimates in minimised. This paper investigates the two methods under some realistic settings to explore any potential differences between them. Simulation studies for six plausible dose-response scenarios show that <italic>D</italic>-optimum design can work well in comparison with the continual reassessment method in many cases. The <italic>D</italic>-optimum design is also found to allocate doses from the extremes of the design region to the patients in a trial.</p></abstract>

The continual reassessment method is a model-based procedure, described in the literature, used to determine the maximum tolerated dose in phase I clinical trials. The maximum tolerated dose can also be found under the framework of D-optimum design, where information is gathered in such a way so that asymptotic variability in the parameter estimates in minimised. This paper investigates the two methods under some realistic settings to explore any potential differences between them. Simulation studies for six plausible dose-response scenarios show that D-optimum design can work well in comparison with the continual reassessment method in many cases. The D-optimum design is also found to allocate doses from the extremes of the design region to the patients in a trial.

A comparison between the continual reassessment method and <italic>D</italic>-optimum design for dose finding in phase I clinical trials

Institute of Statistical Research and Training, University of Dhaka, Dhaka-1000,

Biometrical Letters

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

A comparison between the continual reassessment method and -optimum design for dose finding in phase I clinical trials

The continual reassessment method is a model-based procedure, described in the literature, used to determine the maximum tolerated dose in phase I clinical...

A comparison between the continual reassessment method and D-optimum design for dose finding in phase I clinical trials

Published Online: Dec 10, 2016

Page range: 69 - 82

DOI: https://doi.org/10.1515/bile-2016-0006

Keywords
Dose finding studies, Phase I trial, Maximum tolerated dose, Continual reassessment method, -optimum design

© 2016 M. Iftakhar Alam, published by De Gruyter Open

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

A comparison between the continual reassessment method and D-optimum design for dose finding in phase I clinical trials

Published Online: Dec 10, 2016

Page range: 69 - 82

DOI: https://doi.org/10.1515/bile-2016-0006

KeywordsDose finding studies, Phase I trial, Maximum tolerated dose, Continual reassessment method, -optimum design

© 2016 M. Iftakhar Alam, published by De Gruyter Open

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Keywords
Dose finding studies, Phase I trial, Maximum tolerated dose, Continual reassessment method, -optimum design