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

Liddicoat, Johnathon Edward; Lenarczyk, Gabriela; Aboy, Mateo; Minssen, Timo; Porsdam Mann, Sebastian · NPJ Digit Med · 2025

expert_opinion · Level V

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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.