Category: Clinical trial simulations.
Mediana Designer is a free Windows-based software tool that supports traditional and simulation-based power/sample size calculations in fixed-sample and group-sequential trials.
The current version of Mediana Designer comes with the following three modules:
- TraditionalSampleSize module (Analytical calculations in fixed-sample trials): This module supports traditional analytical evaluation as well as simple simulation-based Bayesian evaluation of operating characteristics in clinical trials with a fixed-sample design.
- TraditionalSimulations module (Simulation-based calculations in fixed-sample trials): This module implements the simulation-based Clinical Scenario Evaluation approach in clinical trials with a fixed-sample design.
- GroupSequential module (Analytical and simulation-based calculations in group-sequential trials): This module implements analytical and simulation-based evaluation of operating characteristics in clinical trials that employ group-sequential designs with several decision points.
Other modules will be added in the future.
It is easy to download Mediana Designer and start using this free software tool:
- Step 1. Download a ZIP archive with a test version of Mediana Designer and required software libraries. The current test version is 0.3.
- Step 2. After downloading the archive, extract the files and place them in the same folder. Note that Mediana Designer relies on a stand-alone executable file (MedianaDesigner.exe) and does not require installation.
- Step 3. Download Mediana Designer project files in a single ZIP archive and extract the files to the folder you created in Step 2. These project files have been created to demonstrate how Mediana Designer can be used to run simple and advanced power and sample size calculations in Phase II and Phase III clinical trials.
- Step 4. Double click on MedianaDesigner.exe to start the software tool and log in to your Mediana account (if you don’t have a Mediana account, you can quickly create a free account).
- Step 5. Select a module and open an existing Mediana Designer project or create a new Mediana Designer project.
Mediana Designer Manual and instructional videos
To learn more about Mediana Designer, visit the help page.
Mediana Designer reports and slide sets
An important feature of Mediana Designer is that it automatically generates reports (Microsoft Word documents) and slide sets (Microsoft PowerPoint presentations) with a detailed summary of operating characteristics of the selected clinical trial.
Download examples of Mediana Designer reports and slide sets in a single ZIP archive.
Mediana Designer’s validation
Multiple commercially available and open-source software tools have been used to test the implementation of statistical methods supported by Mediana Designer. For a detailed summary of procedures that were carried out to test Mediana Designer, visit the validation page.