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
Department of Clinical Pharmacy & Pharmacology, Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.
Department of Respiratory Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.
Lancet Respir Med. 2025 Feb;13(2):177-188. doi: 10.1016/S2213-2600(24)00327-8. Epub 2024 Dec 5.
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.
数字技术（如智能吸入器、可穿戴设备和传感器）能够进行远程、客观、细致且非侵入性的数据收集，这使得它们在评估哮喘等病情发展轨迹多变的气道疾病干预措施的研究中颇具吸引力。此类技术为开展部分或全部在传统临床试验环境之外进行的去中心化临床试验提供了契机，其特点是远程数据收集和监测。这种评估临床、药理或行为干预措施的方法有助于招募具有包容性和代表性的研究人群，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进入市场的时间。这篇个人观点文章讨论了数字技术和终点指标在试验中的应用；混合式和去中心化设计的概念；描述了一项针对哮喘的完全去中心化试验；并从临床医生、患者专家、资源匮乏地区以及监管机构的角度探讨了其实施过程中的优势、劣势、机遇和挑战。
