Evidence map›Paper›PMID 31200907›Full record

ArticleComputer methods and programs in biomedicine2019

CRM2DIM: A SAS macro for implementing the dual-agent Bayesian continual reassessment method.

Mohamed Amine Bayar, Anastasia Ivanova, Gwénaël Le Teuff

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Article in Computer methods and programs in biomedicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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5 · Who and what money

Authors and funding

3 authors.

Mohamed Amine BayarService de Biostatistique et d'Épidémiologie, Gustave Roussy, Villejuif, France; INSERM U1018, CESP, Université Paris-Sud, Université Paris-Saclay, Villejuif, France.
Anastasia IvanovaDepartment of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Gwénaël Le TeuffService de Biostatistique et d'Épidémiologie, Gustave Roussy, Villejuif, France; INSERM U1018, CESP, Université Paris-Sud, Université Paris-Saclay, Villejuif, France. Electronic address: gwenael.leteuff@gustaveroussy.fr.

Funding

Statistical Methods for Cancer Clinical TrialsP01CA142538 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI TSIATIS, ANASTASIOS A · 2010 to 2019
$21.3M
NCI NIH HHS P01 CA142538
6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe 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.

methodsWe 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.

resultsWe 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.

conclusionsThe 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.

Indexed as

Bayes TheoremMaximum Tolerated DoseResearch DesignAlgorithmsClinical Trials, Phase I as TopicDose-Response Relationship, DrugDrug Administration ScheduleHumansLogistic ModelsLongitudinal StudiesMedical OncologyNeoplasmsProgramming LanguagesSoftwareContinual reassessment methodCRMDose-findingDrug combinationsPhase I clinical trialSAS MCMC procedure

Identifiers

PMID31200907
PMCPMC6579114

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.