Augmenting clinical trials in asthma through digital technology, decentralised designs, and person-centric endpoints: opportunities and challenges

Job F M van Boven*, Richard W Costello, Kit C B Roes, Guy G Brusselle, Kjeld Hansen, Jerry A Krishnan, Christopher E Brightling, Nicolas Roche, Salman Siddiqui, Bruce J Kirenga, Hilary Pinnock, Amy H Y Chan

*Corresponding author voor dit werk

Onderzoeksoutputpeer review

2 Citaten (Scopus)

Samenvatting

Digital technologies (eg, smart inhalers, wearables, and sensors) allow for remote, objective, granular, and non-invasive data collection, making them attractive for research evaluating interventions in airways diseases with variable trajectories, such as asthma. Such technologies offer the opportunity to move towards decentralised clinical trials that are done partly or fully outside the classic clinical trial setting and are characterised by remote data collection and monitoring. This approach to evaluating clinical, pharmacological, or behavioural interventions could facilitate recruitment of inclusive and generalisable study populations, enhance personalisation and sustainability, reduce research costs, and accelerate the timeline to novel asthma treatments' market access. This Personal View discusses the application of digital technologies and endpoints within trials; the concept of hybrid and decentralised designs; describes a fully decentralised trial in asthma; and explores the strengths, weaknesses, opportunities, and threats regarding their implementation from the clinician, patient expert, low-resource, and regulator viewpoints.

Originele taal-2English
Pagina's (van-tot)177-188
Aantal pagina's12
TijdschriftThe Lancet. Respiratory Medicine
Volume13
Nummer van het tijdschrift2
Vroegere onlinedatum5-dec.-2024
DOI's
StatusPublished - feb.-2025

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