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.