AI For Pharma Growth E232: The Early Readout: Upgrading the Interim Analysis to Catch Futility and Success Years Sooner
In this episode of AI For Pharma Growth, Dr Andree Bates speaks with Tom Coates, CEO of Presentient, about why interim analysis in clinical trials is ready for a major upgrade.
Interim analyses allow sponsors to look at trial data mid-flight and assess whether a study is likely to succeed or fail, using pre-specified rules. But Tom explains that many phase two and three commercial trials still do not include a pre-planned interim analysis, meaning sponsors often wait far longer than necessary to detect futility or act on early signs of success.
The conversation explores how Presentient is working on next-generation interim analysis and readout strategies, including the BRX platform, which is designed to handle unblinded data while protecting trial integrity. Tom explains why it is not enough to have a powerful algorithm. Sponsors also need secure architecture, audit trails and methods that regulators and data monitoring committees can trust.
Tom also discusses where AI does and does not belong. For high-stakes stop or go decisions, explainability, reproducibility and regulatory confidence matter more than hype. But model-based methods, synthetic data and subgrouping engines may help sponsors better understand which patients benefit, who does not, and how to design trials around more meaningful treatment signals.
The key message is that interim analysis should not be an underused checkpoint. Done well, it can help sponsors stop failing trials earlier, prepare for success sooner and make better decisions with greater confidence.
Topics Covered
Why interim analysis is underused
Stopping trials early for futility or success
Protecting blinding and trial integrity
Secure handling of unblinded data
What data monitoring committees need to see
Where AI fits, and where it does not
Subgrouping and individual treatment effects
Synthetic data and trial simulation
Regulatory confidence and audit trails
The future of continuous trial monitoring
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About the Podcast
AI For Pharma Growth is the podcast from Dr Andree Bates, helping pharma, biotech and healthcare organisations understand how AI-based technologies can save time, grow brands and improve company results. The show demystifies AI for biopharma leaders, from start-up biotech through to Big Pharma.