The continual reassessment method (CRM) is a model-based dose-finding design for single-agent phase I oncology trials. With the advance of targeted therapies in oncology, more and more phase I trials investigate drug combinations rather than a single agent in order to find one or more maximum tolerated dose combinations. Several designs have been proposed for such dose-finding trials but only a few software packages are available to implement them. One of the designs is the two-dimensional Bayesian CRM proposed by Wang and Ivanova. Our goal was to provide an easy-to-use program to implement this design.We developed a new SAS macro, CRM2DIM, for implementing this design. This macro can be used to run a phase I dose-finding trial for two-drug combination and to perform simulations.We describe the program with its different features, including the possibility of running an initial design (start-up rule), the possibility of incorporating historical data, and the choice of using either a power or a logistic regression model with or without interaction term. We illustrate our program by presenting simulation results and by a hypothetical trial example.The CRM2DIM macro provides a SAS implementation of the two-dimensional Bayesian CRM for dual-agent phase I oncology trials. It is an easy-to-use program that includes many useful features and provides statisticians involved in the early phases of development a new tool for designing dual-agent phase I oncology trials.
Description
CRM2DIM: A SAS macro for implementing the dual-agent Bayesian continual reassessment method. - PubMed - NCBI
%0 Journal Article
%1 Bayar:2019:Comput-Methods-Programs-Biomed:31200907
%A Bayar, M A
%A Ivanova, A
%A Le Teuff, G
%D 2019
%J Comput Methods Programs Biomed
%K ClinicalTrials DoseFinding phase1 sas statistics
%P 211-223
%R 10.1016/j.cmpb.2019.04.025
%T CRM2DIM: A SAS macro for implementing the dual-agent Bayesian continual reassessment method
%U https://www.ncbi.nlm.nih.gov/pubmed/31200907
%V 176
%X The continual reassessment method (CRM) is a model-based dose-finding design for single-agent phase I oncology trials. With the advance of targeted therapies in oncology, more and more phase I trials investigate drug combinations rather than a single agent in order to find one or more maximum tolerated dose combinations. Several designs have been proposed for such dose-finding trials but only a few software packages are available to implement them. One of the designs is the two-dimensional Bayesian CRM proposed by Wang and Ivanova. Our goal was to provide an easy-to-use program to implement this design.We developed a new SAS macro, CRM2DIM, for implementing this design. This macro can be used to run a phase I dose-finding trial for two-drug combination and to perform simulations.We describe the program with its different features, including the possibility of running an initial design (start-up rule), the possibility of incorporating historical data, and the choice of using either a power or a logistic regression model with or without interaction term. We illustrate our program by presenting simulation results and by a hypothetical trial example.The CRM2DIM macro provides a SAS implementation of the two-dimensional Bayesian CRM for dual-agent phase I oncology trials. It is an easy-to-use program that includes many useful features and provides statisticians involved in the early phases of development a new tool for designing dual-agent phase I oncology trials.
@article{Bayar:2019:Comput-Methods-Programs-Biomed:31200907,
abstract = {The continual reassessment method (CRM) is a model-based dose-finding design for single-agent phase I oncology trials. With the advance of targeted therapies in oncology, more and more phase I trials investigate drug combinations rather than a single agent in order to find one or more maximum tolerated dose combinations. Several designs have been proposed for such dose-finding trials but only a few software packages are available to implement them. One of the designs is the two-dimensional Bayesian CRM proposed by Wang and Ivanova. Our goal was to provide an easy-to-use program to implement this design.We developed a new SAS macro, CRM2DIM, for implementing this design. This macro can be used to run a phase I dose-finding trial for two-drug combination and to perform simulations.We describe the program with its different features, including the possibility of running an initial design (start-up rule), the possibility of incorporating historical data, and the choice of using either a power or a logistic regression model with or without interaction term. We illustrate our program by presenting simulation results and by a hypothetical trial example.The CRM2DIM macro provides a SAS implementation of the two-dimensional Bayesian CRM for dual-agent phase I oncology trials. It is an easy-to-use program that includes many useful features and provides statisticians involved in the early phases of development a new tool for designing dual-agent phase I oncology trials.},
added-at = {2019-10-13T11:53:22.000+0200},
author = {Bayar, M A and Ivanova, A and Le Teuff, G},
biburl = {https://www.bibsonomy.org/bibtex/2db50d9b8fe81e08826e5351fb3c2fdc9/jkd},
description = {CRM2DIM: A SAS macro for implementing the dual-agent Bayesian continual reassessment method. - PubMed - NCBI},
doi = {10.1016/j.cmpb.2019.04.025},
interhash = {8a77f50906fb10b18486419820d6e6a6},
intrahash = {db50d9b8fe81e08826e5351fb3c2fdc9},
journal = {Comput Methods Programs Biomed},
keywords = {ClinicalTrials DoseFinding phase1 sas statistics},
month = jul,
pages = {211-223},
pmid = {31200907},
timestamp = {2019-10-13T11:53:46.000+0200},
title = {CRM2DIM: A SAS macro for implementing the dual-agent Bayesian continual reassessment method},
url = {https://www.ncbi.nlm.nih.gov/pubmed/31200907},
volume = 176,
year = 2019
}