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Decentralised clinical trials of investigational medicinal products

Lookup NU author(s): Professor Camille CarrollORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2026 The Author(s).Decentralised clinical trials (DCTs) can gather objective data in real-world settings through digital health technologies (DHTs) to obtain real-time measurements of clinical outcomes. However, such measurements remain infrequent in clinical trials of investigational medicinal products (CTIMPs). We review the decentralisation of CTIMPs, identify barriers to passive, real-time DHT use and recommend four solutions: a swift regulatory approval process for DHTs in clinical trials; development of specialised DHTs for CTIMPs; integration of human factors into DHT design for CTIMPs; and the adoption of data collection and transmission standards to enable decentralised CTIMPs to function effectively in patient homes.


Publication metadata

Author(s): Douiri A, Alhnan MA, Asghar MR, Balaskas K, Benaouda F, Bolodeoku J, Campbell-Cooper C, Carroll C, Chen T, Dorricott K, Escudier T, Flohr C, Forbes B, Guy RH, Langouet S, Lockett A, Malek R, May A, McClelland GR, Nasereddin SM, Paredes AJ, Porkess S, Power EGM, Russell REK, Stephens R, Sailem H, Sebastia-Saez D, Sydes MR, Weinman J, Zhao Y, Jones SA

Publication type: Review

Publication status: Published

Journal: Drug Discovery Today

Year: 2026

Volume: 31

Issue: 3

Print publication date: 01/05/2026

Online publication date: 16/04/2026

Acceptance date: 02/04/2018

ISSN (print): 1359-6446

ISSN (electronic): 1878-5832

Publisher: Elsevier Ltd

URL: https://doi.org/10.1016/j.drudis.2026.104676

DOI: 10.1016/j.drudis.2026.104676

PubMed id: 42000125

Data Access Statement: Data availability. All information is available.


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