Shifting to An Open-Source Backbone Within Clinical Trials with Roche and Genentech

Topic: Moving to a fully open-source clinical reporting workflow as the default for clinical trials at Roche

Problem: When pharmaceutical companies wish to get a new drug approved, they must produce hundreds of tables, plots, and listings to provide the evidence for regulators to assess. Traditionally these were produced using a proprietary language with internally developed tools, and the lifecycle of tools could be measured in decades.

In 2023 Roche moved to a new open-source backbone, with packages co-developed with other companies and a new focus on a continually evolving set of tools that are owned and contributed to by the users.

Over 1,000 statisticians and statistical programmers at Roche need to embrace this transition and adapt to a new set of R/Python tools to deploy our new data science focussed workflows.

Solution: Roche approached preparing for the go-live of end-to-end open source trials in a three-pronged strategy:

1. Build a culture that embraces lifelong learning and self-improvement, allowing our data scientists to take on new skills and languages as the industry evolves.
2. Build a plan to ensure study teams are closely supported, with a tight feedback loop between tool developers and the users.
3. Co-create tools by focusing on collaborations like the pharmaverse to pool our efforts and accelerate the development of tools across pharma companies.