Deterministic Automation and / or AI-driven Automation

[orladoylenvs]

Clinical trial analysis now includes both deterministic automation that guarantees repeatability and AI‑driven methods that introduce probabilistic behaviour. For the future of analysis and reporting, should we maintain clear separation between these models, or is a blended approach the most pragmatic path for sponsors and regulators?

[RitaPecuch]

I like the idea of including this topic, especially given how many of the most upvoted proposals are AI-focused. There’s significant value in exploring where deterministic automation can deliver efficient, reliable outcomes without the added complexity of AI. In some cases, the effort required to validate or review AI-generated outputs can outweigh the benefits. It would be highly valuable to facilitate a discussion on how organizations are making informed decisions about when AI is truly justified versus when more traditional automation approaches are the better fit.