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The statistical software revolution in pharmaceutical development: challenges and opportunities in open source
Daniel Sabanés Bové1, Heidi Seibold2, Anne-Laure Boulesteix3
1RCONIS/inferential.biostatistics GmbH, Friedrichstrasse 12, 4055 Basel, Switzerland.
Abstract:
Open-source statistical software development is increasingly the preferred solution for leveraging new statistical methods in the pharmaceutical industry. However, with a long history of relying on licensed analysis software, there are philosophical and organizational barriers to overcome. In particular, the sustainability, reliability, usability, and feasibility of maintaining open-source statistical software long-term must be ensured. Here, we describe the open-source revolution that is emerging in the pharmaceutical industry and how it facilitates greater scaling of innovative analytical methods in statistics. We discuss challenges to open-source software adoption and propose mitigation strategies. Furthermore, we illustrate the potential for open-source software development with examples of successful projects, which highlight the roles of cross-company collaboration, career paths, education, and community building.
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