Category: Clinical trial simulations.
The Mediana package is an R package which provides a framework for general simulation-based power and sample size calculations in fixed-sample trials. This package utilizes the Clinical Scenario Evaluation framework and supports a broad class of data models (including clinical trials with continuous, binary, survival-type and count-type endpoints as well as multivariate outcomes that are based on combinations of different endpoints), analysis strategies and commonly used evaluation criteria.
Expert and development teams
Package design: Alex Dmitrienko (Mediana Inc).
Core development team: Gautier Paux (Servier), Alex Dmitrienko (Mediana Inc).
Extended development team: Thomas Brechenmacher (IQVIA), Fei Chen (Johnson and Johnson), Ilya Lipkovich (IQVIA).
Expert team: Keaven Anderson (Merck), Frank Harrell (Vanderbilt University), Mani Lakshminarayanan (Pfizer), Brian Millen (Lilly), Jose Pinheiro (Johnson and Johnson), Thomas Schmelter (Bayer).
The first version of the Mediana package (Version 1.0.1) was released on July 26, 2015. The latest stable version (Version 1.0.6) can be installed from the CRAN web site:
The latest development version of the Mediana package can be installed from the GitHiub web site:
The package’s online manual is available at: