Extrapolation and Bridging of Adult Information in Early Phase Dose-Finding Paediatrics Studies

A unified method for designing and analysing dose-finding trials in paediatrics, while bridging information from adults, is proposed in the dfped package. The dose range can be calculated under three extrapolation methods: linear, allometry and maturation adjustment, using pharmacokinetic (PK) data. To do this, it is assumed that target exposures are the same in both populations. The working model and prior distribution parameters of the dose-toxicity and dose-efficacy relationships can be obtained using early phase adult toxicity and efficacy data at several dose levels through dfped package. Priors are used into the dose finding process through a Bayesian model selection or adaptive priors, to facilitate adjusting the amount of prior information to differences between adults and children. This calibrates the model to adjust for misspecification if the adult and paediatric data are very different. User can use his/her own Bayesian model written in Stan code through the dfped package. A template of this model is proposed in the examples of the corresponding R functions in the package. Finally, in this package you can find a simulation function for one trial or for more than one trial.


Reference manual

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1.0 by Artemis Toumazi, 2 months ago


Report a bug at http://github.com/artemis-toumazi/dfped/issues

Browse source code at https://github.com/cran/dfped

Authors: Artemis Toumazi <artemis.toumazi@inserm.fr>, Caroline Petit <caroline.petit@crc.jussieu.fr>, Sarah Zohar <sarah.zohar@inserm.fr>

Documentation:   PDF Manual  

GPL (>= 3) license

Imports ggplot2, methods, stats, graphics, grDevices

Depends on rstan, stats4

System requirements: C++11

See at CRAN