通过数字技术、分散设计和以人为中心的终点来扩大哮喘临床试验:机遇与挑战

IF 38.7 1区 医学 Q1 CRITICAL CARE MEDICINE Lancet Respiratory Medicine Pub Date : 2024-12-05 DOI:10.1016/s2213-2600(24)00327-8
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
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引用次数: 0

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、颗粒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)干预措施的研究具有吸引力。这些技术提供了向分散临床试验方向发展的机会,这些临床试验部分或完全在传统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、药理学或行为干预措施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。本个人观点讨论了数字技术和终端在试验中的应用;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、低资源和监管机构的角度探讨其实施的优势、劣势、机会和威胁。
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Augmenting clinical trials in asthma through digital technology, decentralised designs, and person-centric endpoints: opportunities and challenges
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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来源期刊
Lancet Respiratory Medicine
Lancet Respiratory Medicine RESPIRATORY SYSTEM-RESPIRATORY SYSTEM
CiteScore
87.10
自引率
0.70%
发文量
572
期刊介绍: The Lancet Respiratory Medicine is a renowned journal specializing in respiratory medicine and critical care. Our publication features original research that aims to advocate for change or shed light on clinical practices in the field. Additionally, we provide informative reviews on various topics related to respiratory medicine and critical care, ensuring a comprehensive coverage of the subject. The journal covers a wide range of topics including but not limited to asthma, acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD), tobacco control, intensive care medicine, lung cancer, cystic fibrosis, pneumonia, sarcoidosis, sepsis, mesothelioma, sleep medicine, thoracic and reconstructive surgery, tuberculosis, palliative medicine, influenza, pulmonary hypertension, pulmonary vascular disease, and respiratory infections. By encompassing such a broad spectrum of subjects, we strive to address the diverse needs and interests of our readership.
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