A policy framework for leveraging generative AI to address enduring challenges in clinical trials

Johnathon Edward Liddicoat; Gabriela Lenarczyk; Mateo  Aboy; Timo  Minssen; Sebastian Porsdam Mann

doi:10.1038/s41746-025-01440-5

A policy framework for leveraging generative AI to address enduring challenges in clinical trials

Johnathon Edward Liddicoat, Gabriela Lenarczyk, Mateo Aboy, Timo Minssen , Sebastian Porsdam Mann

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Abstract

Can artificial intelligence improve clinical trial design? Despite their importance in medicine, over 40% of trials involve flawed protocols. We introduce and propose the development of application-specific language models (ASLMs) for clinical trial design across three phases: ASLM development by regulatory agencies, customization by Health Technology Assessment bodies, and deployment to stakeholders. This strategy could enhance trial efficiency, inclusivity, and safety, leading to more representative, cost-effective clinical trials.

Original language	English
Article number	33
Journal	npj Digital Medicine
Volume	8
Issue number	1
DOIs	https://doi.org/10.1038/s41746-025-01440-5
Publication status	Accepted/In press - 8 Jan 2025

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A policy framework for leveraging generative AI to address enduring challenges in clinical trials

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