通过数字技术、分散设计和以人为中心的终点扩大哮喘临床试验：机遇和挑战
2025/01/26
摘要
数字技术（如智能吸入器、可穿戴设备和传感器）允许远程、客观、粒状的和无创的数据收集，这使其在评估具有可变轨迹的气道疾病（如哮喘）的干预措施的研究中具有吸引力。这些技术提供了向分散临床试验发展的机会，这些试验部分或全部在经典临床试验环境之外进行，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普适性的研究人群，提高个性化和可持续性，降低研究成本，并加快新型哮喘治疗药物进入市场的时间。本个人化的观点讨论了数字技术的应用和试验中的终点；混合和分散设计的概念；描述了一项完全分散的哮喘试验；并从临床医师、患者专家、低资源和监管机构的角度探讨其实施方面的优势、劣势、机会和威胁。
Augmenting clinical trials in asthma through digital technology, decentralised designs, and person-centric endpoints: opportunities and challenges
Job F M van Boven, Richard W Costello, Kit C B Roes, Guy G Brusselle, Kjeld Hansen, Jerry A Krishnan, Christopher E Brightling, Nicolas Roche, Salman Siddiqui, Bruce J Kirenga, Hilary Pinnock, Amy H Y Chan
Abstract
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）允许远程、客观、粒状的和无创的数据收集，这使其在评估具有可变轨迹的气道疾病（如哮喘）的干预措施的研究中具有吸引力。这些技术提供了向分散临床试验发展的机会，这些试验部分或全部在经典临床试验环境之外进行，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普适性的研究人群，提高个性化和可持续性，降低研究成本，并加快新型哮喘治疗药物进入市场的时间。本个人化的观点讨论了数字技术的应用和试验中的终点；混合和分散设计的概念；描述了一项完全分散的哮喘试验；并从临床医师、患者专家、低资源和监管机构的角度探讨其实施方面的优势、劣势、机会和威胁。
(中日友好医院呼吸与危重症医学科 顾宪民 摘译 林江涛 审校)
(Lancet Respir Med. 2024 Dec 5:S2213-2600(24)00327-8. doi: 10.1016/S2213-2600(24)00327-8.)
(Lancet Respir Med. 2024 Dec 5:S2213-2600(24)00327-8. doi: 10.1016/S2213-2600(24)00327-8.)
Augmenting clinical trials in asthma through digital technology, decentralised designs, and person-centric endpoints: opportunities and challenges
Job F M van Boven, Richard W Costello, Kit C B Roes, Guy G Brusselle, Kjeld Hansen, Jerry A Krishnan, Christopher E Brightling, Nicolas Roche, Salman Siddiqui, Bruce J Kirenga, Hilary Pinnock, Amy H Y Chan
Abstract
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.
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哮喘医疗负担评分的发展：作为严重程度的衡量标准和缓解预测指标在SARP III和U-BIOPRED中的应用：来自两个主要
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LPG 18:0 是哮喘的通用生物标志物，抑制调节性 T 细胞的分化和功能
