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.

中文翻译：

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通过数字技术、分散式设计和以人为本的终点来加强哮喘临床试验：机遇与挑战


数字技术（例如，智能吸入器、可穿戴设备和传感器）允许远程、客观、精细和非侵入性数据收集，使其对评估具有可变轨迹的气道疾病（如哮喘）干预的研究具有吸引力。此类技术为转向分散式临床试验提供了机会，这些试验部分或全部在经典临床试验环境之外完成，其特点是远程数据收集和监控。这种评估临床、药物或行为干预的方法可以促进招募包容性和可推广的研究人群，增强个性化和可持续性，降低研究成本，并加快新型哮喘治疗药物的市场准入时间表。此个人观点讨论了数字技术和终点在试验中的应用;混合和分散设计的概念;描述了一项完全分散的哮喘试验;并从临床医生、患者专家、资源匮乏和监管机构的角度探讨了实施它们的优势、劣势、机会和威胁。