MedianaDesigner (R package)

Category: Clinical trial simulations.

The MedianaDesigner package is an R package that supports efficient simulation-based power and sample size calculations in a broad class of early-stage and late-stage clinical trials. This package relies on multiple C++ libraries to facilitate complex simulations in traditional and adaptive clinical trials.

Functions

The following functions will be included in the first release of MedianaDesigner:

Dose-escalation trials

  • DEBLRM: Simulation-based evaluation of operating characteristics of dose-escalation Phase I trials using Bayesian logistic regression models.

Dose-finding trials

  • DFMCPMod: Simulation-based evaluation of operating characteristics of dose-finding Phase II trials using the MCPMod methodology.

Clinical trials with multiple objectives

  • MATraditionalProcedures: Simulation-based evaluation of operating characteristics of traditional multiple testing procedures in clinical trials with multiple objectives.
  • MAAdvancedProcedures: Simulation-based evaluation of operating characteristics of advanced multiple testing procedures, e.g., gatekeeping procedures, in clinical trials with multiple objectives.

Group-sequential trials

  • GSParameters: Calculation of key design parameters in group-sequential trials.
  • GSCharacteristics: Simulation-based evaluation of operating characteristics of group-sequential trials.

Adaptive trials

  • ADSampleSizeModification: Simulation-based evaluation of operating characteristics of two-stage adaptive trials that support sample size or event count modification at the interim analysis.
  • ADTreatmentSelection: Simulation-based evaluation of operating characteristics of two-stage adaptive trials that support data-driven treatment selection at the interim analysis.
  • ADPopulationSelection: Simulation-based evaluation of operating characteristics of two-stage adaptive trials that support data-driven population selection at the interim analysis.

Traditional Phase II and Phase III trials

  • TDSampleSize: Power and sample size calculations based on closed-form expressions in traditional trials with continuous, binary and time-to-event endpoints.

Other functions will be added in future releases.

Installation

The MedianaDesigner package is currently available only as a development version. It will be released on CRAN in late 2020.