Decentralised clinical trials of investigational medicinal products

Abdel Douiri; Mohamed A. Alhnan; Muhammad Rizwan Asghar; Konstantinos Balaskas; Faiza Benaouda; John Bolodeoku; Clare Campbell-Cooper; Camille Carroll; Tao Chen; Keith Dorricott; Thierry Escudier; Carsten Flohr; Ben Forbes; Richard H. Guy; Stephanie Langouet; Anthony Lockett; Rayka Malek; Angela May; Graham R. McClelland; Sara M. Nasereddin; Alejandro J. Paredes; Sheuli Porkess; Eddie G.M. Power; Richard E.K. Russell; Richard Stephens; Heba Sailem; Daniel Sebastia-Saez; Matthew R. Sydes; John Weinman; Yunlong Zhao; Stuart A. Jones

doi:10.1016/j.drudis.2026.104676

Decentralised clinical trials of investigational medicinal products

Abdel Douiri
, Mohamed A. Alhnan
, Muhammad Rizwan Asghar
, Konstantinos Balaskas
, Faiza Benaouda
, John Bolodeoku
, Clare Campbell-Cooper
, Camille Carroll
, Tao Chen
, Keith Dorricott
, Thierry Escudier
, Carsten Flohr
, Ben Forbes
, Richard H. Guy
, Stephanie Langouet
, Anthony Lockett
, Rayka Malek
, Angela May
, Graham R. McClelland
, Sara M. Nasereddin

Alejandro J. Paredes, Sheuli Porkess, Eddie G.M. Power, Richard E.K. Russell, Richard Stephens, Heba Sailem, Daniel Sebastia-Saez, Matthew R. Sydes, John Weinman, Yunlong Zhao, Stuart A. Jones

King's College London
Guy's Campus
University of Surrey
UCL Institute of Ophthalmology
Fortrea
National Institute for Health and Care Research
Pembroke Rd
Pistoia Alliance
King’s College London
Bayer plc, UK
Amman Arab University
Queen's University Belfast
PM Life Sciences Consulting
emPower Medical LLC
University College London
Health Data Research UK
Imperial College London
Centre for Pharmaceutical Medicine Research

Research output: Contribution to journal › Review article › peer-review

Abstract

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.

Original language	English
Article number	104676
Number of pages	12
Journal	Drug Discovery Today
Volume	31
Issue number	3
Early online date	16 Apr 2026
DOIs	https://doi.org/10.1016/j.drudis.2026.104676
Publication status	Published - 11 May 2026

Data Availability Statement

All information is available.

Funding

Wellcome Career Development Award (HS), MRC (MC_UU_00004/08) (MS), EPSRC EP/X013294/1, EPSRC EP/S021159/1(TC), Royal Society, Applied Microbiology International and EPSRC (AP), Edmond J Safra Foundation, Parkinson’s UK, NIHR, Cure Parkinson’s (CC), King’s Health Partners/Guy’s and St Thomas Charity ‘MLTC Challenge Fund’ (award reference: EIC180702) (AD), EPSRC EP/S021167/1 (SAJ and FB).

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Decentralised
digital health
medicinal
remote
trials

ASJC Scopus subject areas

Pharmacology
Drug Discovery

Access to Document

10.1016/j.drudis.2026.104676Licence: CC BY

Cite this

Douiri, A., Alhnan, M. A., Asghar, M. R., Balaskas, K., Benaouda, F., Bolodeoku, J., Campbell-Cooper, C., Carroll, C., Chen, T., Dorricott, K., Escudier, T., Flohr, C., Forbes, B., Guy, R. H., Langouet, S., Lockett, A., Malek, R., May, A., McClelland, G. R., ... Jones, S. A. (2026). Decentralised clinical trials of investigational medicinal products. Drug Discovery Today, 31(3), Article 104676. https://doi.org/10.1016/j.drudis.2026.104676

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 2026, 'Decentralised clinical trials of investigational medicinal products', Drug Discovery Today, vol. 31, no. 3, 104676. https://doi.org/10.1016/j.drudis.2026.104676

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abstract = "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.",

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AU - Balaskas, Konstantinos

AU - Benaouda, Faiza

AU - Bolodeoku, John

AU - Campbell-Cooper, Clare

AU - Carroll, Camille

AU - Chen, Tao

AU - Dorricott, Keith

AU - Escudier, Thierry

AU - Flohr, Carsten

AU - Forbes, Ben

AU - Guy, Richard H.

AU - Langouet, Stephanie

AU - Lockett, Anthony

AU - Malek, Rayka

AU - May, Angela

AU - McClelland, Graham R.

AU - Nasereddin, Sara M.

AU - Paredes, Alejandro J.

AU - Porkess, Sheuli

AU - Power, Eddie G.M.

AU - Russell, Richard E.K.

AU - Stephens, Richard

AU - Sailem, Heba

AU - Sebastia-Saez, Daniel

AU - Sydes, Matthew R.

AU - Weinman, John

AU - Zhao, Yunlong

AU - Jones, Stuart A.

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Decentralised clinical trials of investigational medicinal products

Abstract

Data Availability Statement

Funding

UN SDGs

Keywords

ASJC Scopus subject areas

Access to Document

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Cite this