|Title||CRM2DIM: A SAS macro for implementing the dual-agent Bayesian continual reassessment method.|
|Publication Type||Journal Article|
|Year of Publication||2019|
|Authors||Bayar, Mohamed Amine, Anastasia Ivanova, and Gwenael Le Teuff|
|Journal||Comput Methods Programs Biomed|
|Date Published||2019 Jul|
|Keywords||Algorithms, Bayes Theorem, Clinical Trials, Phase I as Topic, Dose-Response Relationship, Drug, Drug Administration Schedule, Humans, Logistic Models, Longitudinal Studies, Maximum Tolerated Dose, Medical Oncology, Neoplasms, Programming Languages, Research Design, Software|
BACKGROUND AND OBJECTIVE: 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.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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.
|Alternate Journal||Comput Methods Programs Biomed|
|Original Publication||CRM2DIM: A SAS macro for implementing the dual-agent Bayesian continual reassessment method.|
|PubMed Central ID||PMC6579114|
|Grant List||P01 CA142538 / CA / NCI NIH HHS / United States|
CRM2DIM: A SAS macro for implementing the dual-agent Bayesian continual reassessment method.