dfped - 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. These
methods are proposed by Petit et al, (2016)
<doi:10.1177/0962280216671348>.
