From left to right: Andrea Manfrin, Deputy Director, Clinical Investigations, MHRA; Lisbeth Bregnhoj, GCP Inspector, Danish Medicines Agency; Gabriel Westman, Head of AI, Swedish Medical Products Agency; Thierry Escudier, Portfolio Lead, Pistoia Alliance
Regulators keen for earlier engagement from pharma on AI, while poll reveals social media’s growing role in patient-centric drug development
London, UK, 28 May, 2026 – The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has released new poll data showing trust and regulatory uncertainty are the biggest barriers to AI adoption in clinical trials, cited by half of respondents (50%). 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. The panel rightly emphasized 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,” comments Dr Becky Upton, President of the Pistoia Alliance. “Regulators are not the enemy. They can be partners to pharma, working together to formalize 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.”
The poll data show 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 realizing it. Respondents said that over the next 3-5 years, AI will have the most impact on cleaning data, data analysis and insight generation (48%) and sourcing and engaging patients (22%).
“It is exciting that so many potential new therapies are emerging as more AI-discovered candidates successfully move downstream. But this influx also means more programs are competing for the same trial sites and patient populations. The poll shows clinical development professionals believe AI can help address some of these pressures, particularly in sourcing and engaging patients, which remains one of the industry’s most persistent challenges,” said Zahid Tharia, Director of Open Pharma Research, organizers of CTTC. “Our Congress was a great start to exploring how technologies like AI can support the industry as it moves towards more patient-centric development. We look forward to seeing how these trends continue to unfold at our 2027 Congress.”
The poll also examined the value of real-world data, including social media listening, in shaping clinical development operations. It found that 60% of respondents are already using, piloting or exploring patient-generated data to inform clinical development decisions beyond marketing. More than half (58%) say the primary benefit of social media listening is understanding patient needs, monitoring sentiment and experience.
“The data show that pharma recognizes the value of social media as an opportunity to hear the unfiltered patient voice. Collecting data from outside of traditional trial settings is becoming increasingly important as drug development seeks to become more patient-centred. The next step is ensuring these data are being collected in an ethical and standardized way,” comments Thierry Escudier, Clinical Portfolio Lead at the Pistoia Alliance. “The Alliance has already started this work by developing a best-practice framework for the ethical use of social media data, and we want to build on this work as we expand our role in the clinical space. We’re calling on pharma companies to come forwards to fund and suggest new projects in the clinical space.”
To get involved in the Pistoia Alliance’s projects that are helping to accelerate late-stage R&D, visit www.pistoiaalliance.org/strategic-priorities.
For information on CTTC, visit: www.ctt-congress.com.