Assessment of priorities, quality, and inclusivity of digital therapeutics trials in China

Abstract Digital therapeutics (DTx) are software-driven solutions for prevention, treatment, and management of medical conditions. Despite a pro-DTx momentum in China, global DTx trial assessments overlooked the country. We identified 756 DTx trials in China and analyzed their characteristics and qu...

Full description

Saved in:
Bibliographic Details
Main Authors: Ziming Wang, Xinxin Xia, Weijia Lu, Yuguo Ye, Jin Xu
Format: Article
Language:English
Published: Nature Portfolio 2025-02-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-025-01477-6
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1823861573891915776
author Ziming Wang
Xinxin Xia
Weijia Lu
Yuguo Ye
Jin Xu
author_facet Ziming Wang
Xinxin Xia
Weijia Lu
Yuguo Ye
Jin Xu
author_sort Ziming Wang
collection DOAJ
description Abstract Digital therapeutics (DTx) are software-driven solutions for prevention, treatment, and management of medical conditions. Despite a pro-DTx momentum in China, global DTx trial assessments overlooked the country. We identified 756 DTx trials in China and analyzed their characteristics and quality parameters. Over 70% were funded by governments, hospitals, and universities, with tertiary hospitals in eastern China leading most trials. 44.8% used automated DTx, with 39.2% DTx-guided. Most trials focused on management (52.5%) and treatment (38.1%), with few on prevention (9.4%). Mental, behavioral, or neurodevelopmental disorders represented the leading condition category of focus. Recent declines in median sample size, median duration, and mean number of sites were noted. Only 18% of trials were at low overall risk of bias. While recognizing the rapid development of DTx trials in China, we call for better trial design and methodological rigor, prioritization of preventive and primary care, wider condition category scope, and higher inclusivity.
format Article
id doaj-art-8768e7292c7544de86f589bac7441c40
institution Kabale University
issn 2398-6352
language English
publishDate 2025-02-01
publisher Nature Portfolio
record_format Article
series npj Digital Medicine
spelling doaj-art-8768e7292c7544de86f589bac7441c402025-02-09T12:55:40ZengNature Portfolionpj Digital Medicine2398-63522025-02-01811810.1038/s41746-025-01477-6Assessment of priorities, quality, and inclusivity of digital therapeutics trials in ChinaZiming Wang0Xinxin Xia1Weijia Lu2Yuguo Ye3Jin Xu4China Center for Health Development Studies, Peking University, Xueyuan RoadChina Center for Health Development Studies, Peking University, Xueyuan RoadChina Center for Health Development Studies, Peking University, Xueyuan RoadChina Center for Health Development Studies, Peking University, Xueyuan RoadChina Center for Health Development Studies, Peking University, Xueyuan RoadAbstract Digital therapeutics (DTx) are software-driven solutions for prevention, treatment, and management of medical conditions. Despite a pro-DTx momentum in China, global DTx trial assessments overlooked the country. We identified 756 DTx trials in China and analyzed their characteristics and quality parameters. Over 70% were funded by governments, hospitals, and universities, with tertiary hospitals in eastern China leading most trials. 44.8% used automated DTx, with 39.2% DTx-guided. Most trials focused on management (52.5%) and treatment (38.1%), with few on prevention (9.4%). Mental, behavioral, or neurodevelopmental disorders represented the leading condition category of focus. Recent declines in median sample size, median duration, and mean number of sites were noted. Only 18% of trials were at low overall risk of bias. While recognizing the rapid development of DTx trials in China, we call for better trial design and methodological rigor, prioritization of preventive and primary care, wider condition category scope, and higher inclusivity.https://doi.org/10.1038/s41746-025-01477-6
spellingShingle Ziming Wang
Xinxin Xia
Weijia Lu
Yuguo Ye
Jin Xu
Assessment of priorities, quality, and inclusivity of digital therapeutics trials in China
npj Digital Medicine
title Assessment of priorities, quality, and inclusivity of digital therapeutics trials in China
title_full Assessment of priorities, quality, and inclusivity of digital therapeutics trials in China
title_fullStr Assessment of priorities, quality, and inclusivity of digital therapeutics trials in China
title_full_unstemmed Assessment of priorities, quality, and inclusivity of digital therapeutics trials in China
title_short Assessment of priorities, quality, and inclusivity of digital therapeutics trials in China
title_sort assessment of priorities quality and inclusivity of digital therapeutics trials in china
url https://doi.org/10.1038/s41746-025-01477-6
work_keys_str_mv AT zimingwang assessmentofprioritiesqualityandinclusivityofdigitaltherapeuticstrialsinchina
AT xinxinxia assessmentofprioritiesqualityandinclusivityofdigitaltherapeuticstrialsinchina
AT weijialu assessmentofprioritiesqualityandinclusivityofdigitaltherapeuticstrialsinchina
AT yuguoye assessmentofprioritiesqualityandinclusivityofdigitaltherapeuticstrialsinchina
AT jinxu assessmentofprioritiesqualityandinclusivityofdigitaltherapeuticstrialsinchina