Poll highlights trust and regulatory concerns over AI in clinical trials
Trust and regulatory uncertainty remain the biggest barriers to artificial intelligence adoption in clinical trials, according to new polling released by the Pistoia Alliance.
The findings were gathered during the Clinical Trials Technology Congress in London, where the organisation hosted a panel discussion involving regulators from the MHRA, Danish Medicines Agency and Swedish Medical Products Agency.
Half of respondents identified trust and regulatory uncertainty as the main obstacles to wider AI implementation in clinical development.
Despite these concerns, respondents reported growing evidence of value from AI deployment. According to the poll, 42% are already seeing early signs of return on investment, while a further 23% expect benefits but have yet to realise them.
Participants identified data cleaning, data analysis and insight generation as the areas most likely to be transformed by AI over the next three to five years, followed by patient sourcing and engagement.
Dr Becky Upton (pictured), president of the Pistoia Alliance, said discussions at the congress suggested regulators were increasingly open to AI adoption, provided implementation remains transparent and appropriately governed.
“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,” she said.
“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.”
The poll also examined attitudes towards real-world data and social media listening. Sixty per cent of respondents said they are already using, piloting or exploring patient-generated data to inform clinical development activities beyond marketing applications.
More than half identified social media monitoring as a valuable way of understanding patient needs, experiences and sentiment.
Thierry Escudier, clinical portfolio lead at the Pistoia Alliance, said collecting data outside traditional trial settings is becoming increasingly important as drug development becomes more patient-centred.
“The data show that pharma recognises the value of social media as an opportunity to hear the unfiltered patient voice,” he said.
He added that ensuring patient-generated data are collected ethically and consistently will be a key challenge as adoption grows.
The Alliance said it has already begun work on best-practice frameworks for the ethical use of social media data and is seeking additional industry collaboration on future clinical research projects.
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