ASSISTant {ASSISTant}

Three stage group sequential adaptive design with subgroup selection

Description

ASSISTant is a package that implements a three-stage adaptive clinical trial design with provision for subgroup selection where the treatment may be effective; see Lai, Lavori and Liao (doi:10.1016/j.cct.2014.09.001). The main design object is an R6 class that can be instantiated and manipulated to obtain the operating characteristics. A vignette is provided showing the use of this package for designing the DEFUSE-3 trial, described in the paper by Lai, Lavori and Liao. The package contains everything necessary to reproduce the results of the paper.

References

Adaptive Choice of Patient Subgroup for Comparing Two Treatments by Tze Leung Lai and Philip W. Lavori and Olivia Yueh-Wen Liao. Contemporary Clinical Trials, Vol. 39, No. 2, pp 191-200 (2014, doi:10.1016/j.cct.2014.09.001).

Adaptive design of confirmatory trials: Advances and challenges by Tze Leung Lai and Philip W. Lavori and Ka Wai Tsang. Contemporary Clinical Trials, Vol. 45, Part A, pp 93-102 (2015, doi:10.1016/j.cct.2015.06.007).