Trust and regulation holding back AI in clinical trials 

The use of AI in clinical trials is being held back by a lack of trust and regulatory uncertainty, professionals say. 

A poll from The Pistoia Alliance found that half of respondents agreed trust and regulatory uncertainty were barriers to AI adoption in clinical trials. 

The results showed that AI is beginning to deliver value in clinical development, with 42% of respondents seeing early signs of Return on Investment (ROI) and a further 23% expecting ROI but not yet realising it.  

Respondents said that over the next three to five years, AI will have the most impact on cleaning data, data analysis and insight generation (48%) and sourcing and engaging patients (22%).   

The poll was conducted at the Clinical Trials Technology Congress (CTTC) in London, where the Alliance hosted a panel with regulators from the MHRA, Danish Medicines Agency and Swedish Medical Products Agency. 

“A recurring message at the Congress was that regulators are ready to embrace AI, and are keen for pharma companies to engage early to ensure adoption is safe and compliant,” said Dr Becky Upton, President of the Pistoia Alliance. 

“The panel rightly emphasised that speed without control is not enough when patient safety is at stake. For AI to support clinical development at scale, the industry needs validated, auditable and explainable approaches, not black-box models that create uncertainty for sponsors and regulators alike. 

“Regulators are not the enemy. They can be partners to pharma, working together to formalise AI guidance that supports both sides. This is exactly where the Pistoia Alliance helps, by convening pre-competitive working groups that bring pharma, technology providers and regulators together around common frameworks.” 

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