About this episode

Dr Andree Bates discusses the need for upgrading interim analysis in clinical trials with Tom Coates, CEO of Presentient.

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…

People in this episode

Host: Dr Andree Bates

Guest: Tom Coates

Topics covered

• interim analysis
• clinical trials
• AI in pharma
• data integrity
• regulatory confidence

Keywords

• interim analysis
• clinical trials
• futility
• success
• AI
• data monitoring
• BRX platform

Mentioned in this episode

Organizations: Presentient

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