Biopharmaceutical Software Working Group

Category: Clinical trial simulations.

Working group

The Biopharmaceutical Software Working Group is sponsored by the Biopharmaceutical Section of the American Statistical Association. The Working Group is planning to solicit ideas for new software tools with biopharmaceutical applications (including R-based software and free Windows-based software packages with a graphical user interface), set up a network of testers and reviewers, and ultimately cultivate a community focused on the development of software tools for biopharmaceutical statisticians by biopharmaceutical statisticians.

Membership

Core team: Neby Bekele (Gilead), Thomas Brechenmacher (IQVIA), Alex Dmitrienko (Mediana Inc) [Chair], Dacheng Liu (Boehringer Ingelheim), Brian Millen (Eli Lilly), Christoph Muysers (Bayer), Kaushik Patra (Alexion), Gautier Paux (Sanofi), Kyle Wathen (J&J) [Vice Chair].
Members at large: Keaven Anderson (Merck), Richard Zink (Target Pharmasolutioni).

Goals

The current set of the Working Group’s goals includes:

  • Identify the gaps in the availability of software tools that facilitate the design, conduct and analysis of clinical trials with emphasis on tools that enable efficient clinical trial simulations.
  • Develop best practices for clinical trials simulations.
  • Develop general guidelines and more detailed specifications for statistical software tools, including software testing/validation guidelines.
  • Identify and collaborate with software developers to build free statistical software tools based on the specifications created by the working group.
  • Create a network of reviewers for testing the statistical software tools designed by the working group and gathering feedback to inform the next steps of the software development process.
  • Develop documentation and other instructional materials, including free training videos on the Biopharmaceutical Section’s YouTube channel, for the software tools.
  • Prepare publications, organize conference presentations and develop training courses to introduce the software tools designed by the working group to the biostatistical and clinical trial communities.

The goals are expected to be reviewed and revised on a regular basis.

Software tools

Mediana package (R package for general simulation-based power and sample size calculations in fixed-sample trials).
Mediana Designer (free Windows-based software tool for traditional and simulation-based power/sample size calculations in fixed-sample and group-sequential trials).