Mediana Designer

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.

Applications

The current version of Mediana Designer comes with the following three applications:

  • Application 1 (Analytical calculations in fixed-sample trials): This application supports analytical evaluation of operating characteristics in clinical trials with a fixed-sample design.
  • Application 2 (Simulation-based calculations in fixed-sample trials): This application implements the simulation-based Clinical Scenario Evaluation approach in clinical trials with a fixed-sample design.
  • Application 3 (Analytical and simulation-based calculations in group-sequential trials): This application implements analytical and simulation-based evaluation of operating characteristics in clinical trials that employ group-sequential designs with several decision points.

Other applications will be added in the future.

Download Mediana Designer

Download a ZIP archive with a test version of Mediana Designer and required libraries (9 files). The current test version is 0.1.

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. Double click on MedianaDesigner.exe to start the software tool.

Mediana Designer project files

Multiple project files have been created to demonstrate how Mediana Designer can be used to perform power and sample size calculations in Phase II and Phase III clinical trials.

Application 1

The following project files with the file extension MD1 can be used to perform traditional (frequentist) and Bayesian calculations in fixed-sample clinical trials:

  • Application 1 Case study 1.md1: Power and sample size calculations in a two-arm trial with a continuous endpoint.
  • Application 1 Case study 2.md1: Power and sample size calculations in a two-arm trial with a binary endpoint.
  • Application 1 Case study 3.md1: Power and sample size calculations in a two-arm trial with a time-to-event endpoint.
  • Application 1 Case study 4.md1: Power and sample size calculations in a two-arm trial with a time-to-event endpoint (includes patient accrual and dropout modeling).

Application 2

The following project files with the file extension MD2 can be used to perform simulation-based calculations based on the Clinical Scenario Evaluation approach in fixed-sample clinical trials:

  • Application 2 Case study 1.md2: Power calculations in a two-arm trial with a continuous endpoint.
  • Application 2 Case study 2.md2: Power calculations in a two-arm trial with a binary endpoint.
  • Application 2 Case study 3.md2: Power calculations in a two-arm trial with a time-to-event endpoint.
  • Application 2 Case study 4.md2: Power calculations in a two-arm trial with a time-to-event endpoint (includes patient accrual and dropout modeling).
  • Application 2 Case study 5.md2: Power calculations in a four-arm trial with a continuous endpoint (includes a comparison of candidate multiplicity adjustments).
  • Application 2 Case study 6.md2: Power calculations in a two-arm trial with a continuous endpoint and two pre-defined patient populations (includes a comparison of candidate multiplicity adjustments).

Application 3

The following project files with the file extension MD3 can be used to perform analytical and simulation-based calculations in group-sequential clinical trials:

  • Application 3 Case study 1.md3: Power and sample size calculations in a two-arm group-sequential trial with a continuous endpoint.
  • Application 3 Case study 2.md3: Power and sample size calculations in a two-arm group-sequential trial trial with a time-to-event endpoint.

More project files will be added in the future.

Download all Mediana Designer project files in a single ZIP archive.

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 all Mediana Designer reports and slide sets for the case studies listed above in a single ZIP archive.