TY - JOUR
T1 - Augmenting clinical trials in asthma through digital technology, decentralised designs and person-centric endpoints: 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
PY - 2024/12/5
Y1 - 2024/12/5
N2 - Digital technologies (e.g., smart inhalers, wearables and sensors) allow for remote, objective, granular and noninvasive data collection, making the concept attractive for research evaluating interventions in airways diseases with variable trajectories such as asthma. Digital technologies offer the opportunity to move towards decentralised clinical trials, which are performed partly or fully outside the classical clinical trial setting and are characterized by remote data collection and monitoring. This approach to evaluating clinical, pharmacological or behavioral 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 with regards to their implementation from the clinician, patient expert, low-resource and regulator viewpoints.
AB - Digital technologies (e.g., smart inhalers, wearables and sensors) allow for remote, objective, granular and noninvasive data collection, making the concept attractive for research evaluating interventions in airways diseases with variable trajectories such as asthma. Digital technologies offer the opportunity to move towards decentralised clinical trials, which are performed partly or fully outside the classical clinical trial setting and are characterized by remote data collection and monitoring. This approach to evaluating clinical, pharmacological or behavioral 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 with regards to their implementation from the clinician, patient expert, low-resource and regulator viewpoints.
U2 - 10.1016/S2213-2600(24)00327-8
DO - 10.1016/S2213-2600(24)00327-8
M3 - Article
SN - 2213-2600
JO - The Lancet Respiratory Medicine
JF - The Lancet Respiratory Medicine
ER -