Language
English
Publication Date
5-1-2025
Journal
The Lancet Digital Health
DOI
10.1016/j.landig.2025.01.007
PMID
40360351
PMCID
PMC12171946
PubMedCentral® Posted Date
6-17-2025
PubMedCentral® Full Text Version
Author MSS
Abstract
Randomised controlled trials are the gold standard to assess the effectiveness and safety of clinical interventions; however, many paediatric trials are discontinued early due to challenges in patient enrolment. Hence, most paediatric clinical trials suffer from lack of adequate power. Additionally, trials are expensive and might expose patients to unproven therapies. Alternatives to overcome these issues using virtual patient data—namely, digital twins, synthetic patient data, and in-silico trials—are now possible due to rapid advances in digital health-care tools and interventions. However, such digital innovations have been rarely used in paediatric trials. In this Viewpoint, we propose using virtual patient data to empower paediatric trials. The use of virtual patient data has the advantages of decreased exposure of children to potentially ineffective or risky interventions, shorter trial durations leading to more rapid ascertainment of safety and effectiveness of interventions, and faster drug approvals. Use of virtual patient data could lead to more personalised treatment options with low costs and could result in faster clinical implementation of interventions in children. However, ethical and regulatory concerns, including replacing humans with digital data, data privacy, and security should be addressed and the safety and sustainability of digital data innovation ensured before virtual patient data are adopted widely.
Keywords
Humans, Child, Pediatrics, Clinical Trials as Topic, Computer Simulation
Published Open-Access
yes
Recommended Citation
Pammi, Mohan; Shah, Prakesh S; Yang, Liu K; et al., "Digital Twins, Synthetic Patient Data, and In-Silico Trials: Can They Empower Paediatric Clinical Trials?" (2025). Faculty and Staff Publications. 5951.
https://digitalcommons.library.tmc.edu/baylor_docs/5951