MAMS

Designing multi-arm multi stage studies

This package allows to design multi-arm multi-stage (MAMS) studies with asymptotically normal endpoints and known variance. It considers normal, binary, ordinal and time-to-event endpoints in which either the single best treatment or all promising treatments are continued at the interim analyses.

Installation

You can install the latest released version from CRAN from within R:

install.packages("MAMS")

Details

Currently implemented functions are:

• mams(): a function allowing to design multi-arm multi-stage studies with normal endpoints,

• new.bounds(): a function allowing to update the lower and upper boundaries of a multi-arm multi-stage study, typically initally defined by mams(), based on observed sample sizes,

• mams.sim(): a function allowing to simulate multi-arm multi-stage studies given chosen boundaries and sample size, and estimates power and expected sample size,

• stepdown.mams(): a function allowing to find stopping boundaries for a 2- or 3-stage (stepdown) multiple-comparisons-with-control test,

• stepdown.update(): a function allowing to update the stopping boundaries of a multi-arm multi-stage study, typically initally defined by stepdown.mams(), at an interim analysis as well as allowing for unplanned treatment selection and/or sample-size reassessment,

• ordinal.mams(): a function allowing to design multi-arm multi-stage studies with ordinal or binary endpoints,

• tite.mams(): a function allowing to design multi-arm multi-stage studies with time-to-event endpoints.

  We refer to Jaki et al (2019) for an overview of the package as well as to Magirr et al (2012) and Magirr et al (2014) for theoretical details.