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The Lancet. Respiratory medicine · 2024

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

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

Аннотация

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.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты