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

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 re...

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Main Authors: Johnathon Edward Liddicoat, Gabriela Lenarczyk, Mateo Aboy, Timo Minssen, Sebastian Porsdam Mann
Format: Article
Language:English
Published: Nature Portfolio 2025-01-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-025-01440-5
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author Johnathon Edward Liddicoat
Gabriela Lenarczyk
Mateo Aboy
Timo Minssen
Sebastian Porsdam Mann
author_facet Johnathon Edward Liddicoat
Gabriela Lenarczyk
Mateo Aboy
Timo Minssen
Sebastian Porsdam Mann
author_sort Johnathon Edward Liddicoat
collection DOAJ
description 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.
format Article
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institution Kabale University
issn 2398-6352
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publisher Nature Portfolio
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series npj Digital Medicine
spelling doaj-art-6c43ee3502f64e1499ec23e38cdf95632025-01-19T12:39:50ZengNature Portfolionpj Digital Medicine2398-63522025-01-01811510.1038/s41746-025-01440-5A policy framework for leveraging generative AI to address enduring challenges in clinical trialsJohnathon Edward Liddicoat0Gabriela Lenarczyk1Mateo Aboy2Timo Minssen3Sebastian Porsdam Mann4Dickson Poon School of Law, King’s College LondonCenter for Advanced Studies in Bioscience Innovation Law (CeBIL), Faculty of Law, University of CopenhagenCentre for Law, Medicine and Life Sciences and Centre for Intellectual Property & Information Law, Faculty of Law, University of CambridgeCenter for Advanced Studies in Bioscience Innovation Law (CeBIL), Faculty of Law, University of CopenhagenCenter for Advanced Studies in Bioscience Innovation Law (CeBIL), Faculty of Law, University of CopenhagenCan 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.https://doi.org/10.1038/s41746-025-01440-5
spellingShingle Johnathon Edward Liddicoat
Gabriela Lenarczyk
Mateo Aboy
Timo Minssen
Sebastian Porsdam Mann
A policy framework for leveraging generative AI to address enduring challenges in clinical trials
npj Digital Medicine
title A policy framework for leveraging generative AI to address enduring challenges in clinical trials
title_full A policy framework for leveraging generative AI to address enduring challenges in clinical trials
title_fullStr A policy framework for leveraging generative AI to address enduring challenges in clinical trials
title_full_unstemmed A policy framework for leveraging generative AI to address enduring challenges in clinical trials
title_short A policy framework for leveraging generative AI to address enduring challenges in clinical trials
title_sort policy framework for leveraging generative ai to address enduring challenges in clinical trials
url https://doi.org/10.1038/s41746-025-01440-5
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