Wang Changwon, Lee Chungkeun, Shin Hangsik
Biomedical Engineering Research Center, Asan Medical Center, Seoul, 05505, Republic of Korea.
Digital Health Devices Division, Medical Device Evaluation Department, National Institute of Food and Drug Evaluation, Ministry of Food and Drug Safety, Osong, 28159, Republic of Korea.
NPJ Digit Med. 2023 Mar 10;6(1):38. doi: 10.1038/s41746-023-00777-z.
As a new therapeutic technique based on digital technology, the commercialization and clinical application of digital therapeutics (DTx) are increasing, and the demand for expansion to new clinical fields is remarkably high. However, the use of DTx as a general medical component is still ambiguous, and this ambiguity may be owing to a lack of consensus on a definition, in addition to insufficiencies in research and development, clinical trials, standardization of regulatory frameworks, and technological maturity. In this study, we conduct an in-depth investigation and analysis of definitions, clinical trials, commercial products, and the regulatory status related to DTx using published literature, ClinicalTrials.gov, and web pages of regulatory and private organizations in several countries. Subsequently, we suggest the necessity and considerations for international agreements on the definition and characteristics of DTx, focusing on the commercialization characteristics. In addition, we discuss the status and considerations of clinical research, key technology factors, and the direction of regulatory developments. In conclusion, for the successful settlement of DTx, real-world evidence-based validation should be strengthened by establishing a cooperative system between researchers, manufacturers, and governments, and there should be effective technologies and regulatory systems for overcoming engagement barriers of DTx.
作为一种基于数字技术的新型治疗技术，数字疗法（DTx）的商业化和临床应用正在不断增加，向新临床领域扩展的需求也非常高。然而，DTx作为一种通用医疗组件的使用仍不明确，这种不明确可能是由于除了研发、临床试验、监管框架标准化和技术成熟度不足之外，在定义上缺乏共识。在本研究中，我们利用已发表的文献、ClinicalTrials.gov以及几个国家监管机构和私营组织的网页，对与DTx相关的定义、临床试验、商业产品和监管状况进行了深入调查和分析。随后，我们建议就DTx的定义和特征达成国际协议的必要性及注意事项，重点关注商业化特征。此外，我们还讨论了临床研究的现状及注意事项、关键技术因素以及监管发展方向。总之，为了DTx的成功推广，应通过建立研究人员、制造商和政府之间的合作系统，加强基于真实世界证据的验证，并且应有有效的技术和监管系统来克服DTx的应用障碍。
