TY - JOUR
T1 - Augmenting clinical trials in asthma through digital technology, decentralised designs, and person-centric endpoints
T2 - opportunities and challenges
AU - van Boven, Job F M
AU - Costello, Richard W
AU - Roes, Kit C B
AU - Brusselle, Guy G
AU - Hansen, Kjeld
AU - Krishnan, Jerry A
AU - Brightling, Christopher E
AU - Roche, Nicolas
AU - Siddiqui, Salman
AU - Kirenga, Bruce J
AU - Pinnock, Hilary
AU - Chan, Amy H Y
N1 - Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.
PY - 2025/2
Y1 - 2025/2
N2 - 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.
AB - 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.
KW - asthma
KW - decentralised clinical trial
KW - digital technology
KW - medication adherence
KW - PATIENT OUTCOMES
KW - EHEALTH
KW - smart inhaler
KW - electronic monitoring
KW - DEVICES
U2 - 10.1016/S2213-2600(24)00327-8
DO - 10.1016/S2213-2600(24)00327-8
M3 - Review article
C2 - 39647486
SN - 2213-2600
VL - 13
SP - 177
EP - 188
JO - The Lancet. Respiratory Medicine
JF - The Lancet. Respiratory Medicine
IS - 2
ER -