Yao Han, Liao Zirui, Zhang Xinyi, Zhang Xiaoke, Li Mengyu, You Lili, Liu Yuanli
School of Health Policy and Management, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China.
National Clinical Research Center for Infectious Disease, Shenzhen Third People's Hospital, Shenzhen, Guangdong Province, 518112, China.
Heliyon. 2024 Aug 10;10(16):e36115. doi: 10.1016/j.heliyon.2024.e36115. eCollection 2024 Aug 30.
Digital therapeutics (DTx) is an emerging and groundbreaking medical intervention that utilizes health software to treat or alleviate various diseases, disorders, conditions, or injuries. Although the potential of digital therapy is enormous, it is still in its nascent stage and faces multiple challenges and obstacles. The purpose of this study is to provide an overview of all DTx-related clinical trials in ClinicalTrials.gov and to promote the advancement of DTx.
Two reviewers and one expert evaluated data from all DTx clinical trials on ClinicalTrials.gov as of August 8, 2023. Trials utilizing digital therapeutics independently or in combination with traditional approaches were included. Incomplete trials and those lacking an evidence-based foundation were excluded. Basic information about product launches and primary outcome measures was extracted and analyzed.
A total of 280 eligible trials were categorized into treating a disease (141, 50.4 %), managing a disease (120, 42.9 %), and improving a health function (19, 6.8 %). The focus was primarily on mental and behavioral disorders, neurological disorders, and endocrine, nutritional, and metabolic disorders. The number of trials has been increasing annually, yet trial design and conduct remain inconsistent. Randomized controlled trials (RCTs) accounted for 67.5 % of completed trials, and 36 trials (12.9 %) involved products already approved for marketing.
The growth in clinical studies on DTx underscores their potential in healthcare. However, challenges persist in standardization, regulation, and clinical efficacy. There is a need for a harmonized global classification of digital therapeutics and standardized clinical trial protocols to ensure efficacy and improve healthcare services.
数字疗法（DTx）是一种新兴的、具有开创性的医学干预手段，它利用健康软件来治疗或缓解各种疾病、紊乱、病症或损伤。尽管数字疗法的潜力巨大，但它仍处于起步阶段，面临着多重挑战和障碍。本研究的目的是概述ClinicalTrials.gov上所有与DTx相关的临床试验，并推动数字疗法的发展。
两名评审员和一名专家评估了截至2023年8月8日ClinicalTrials.gov上所有DTx临床试验的数据。纳入了独立使用数字疗法或与传统方法联合使用数字疗法的试验。排除了不完整的试验和缺乏循证基础的试验。提取并分析了有关产品发布和主要结局指标的基本信息。
共有280项符合条件的试验被分类为治疗疾病（141项，50.4%）；管理疾病（120项，42.9%）；改善健康功能（19项，6.8%）。重点主要集中在精神和行为障碍、神经疾病以及内分泌、营养和代谢紊乱方面。试验数量逐年增加，但试验设计和实施仍不一致。随机对照试验（RCT）占已完成试验的67.5%，36项试验（12.9%）涉及已获批准上市的产品。
DTx临床研究的增长凸显了其在医疗保健领域的潜力。然而，在标准化、监管和临床疗效方面仍存在挑战。需要对数字疗法进行统一的全球分类，并制定标准化的临床试验方案，以确保疗效并改善医疗服务。
