Mediana Designer’s project files

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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. The application-specific projects are described below.

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 can be downloaded in a single ZIP archive:

  • Test Version 0.3: Download a ZIP archive with Mediana Designer project files.