Development and Validation of a Digital Twin-based Clinical Research System (X Town Stage I)

ConditionChronic Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorShanghai 6th People's Hospital

About this trial

Chronic diseases, characterized by their prolonged duration and slow progression, have emerged as predominant contributors to global morbidity and mortality. The investigators have developed a digital twin-based clinical research system (termed X Town) for chronic diseases, to predict clinical outcomes under various interventions. In this study, the investigators aim to evaluate the reliability of the developed digital twin-based clinical research system in predicting short-term clinical outcomes via virtual and real-world clinical studies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18 years old

Receiving care at a community health service centre

Able to understand and comply with the study procedures

Agrees to participate in the study and signs the informed consent form

Disqualifiers

Patients with severe mental illness

Patients expected to be unable to complete follow-ups

Trial population

We will mainly include participants at high-risk of or with chronic diseases.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,500 Participants

are grouped into 2 trial groups

Group A: Virtual clinical studies

Group B: Real-world clinical studies

Trial outcomes

Primary outcomes

The agreement between the simulated short-term clinical outcomes in the virtual clinical studies and the real-world short-term clinical outcomes in the real-world clinical studies

We will use three predefined binary metrics to evaluate the agreement: (1) full statistical significance agreement, defined by effect estimates and CIs of the virtual and real-world clinical studies on the same side of the null; (2) estimate agreement, defined by whether effect estimates for the virtual clinical studies fell within the 95% CI for the real-world clinical study results; (3) standardized difference agreement between treatment effect estimates from the real-world clinical studies and the virtual clinical studies, defined by standardized differences (Reference: JAMA. 2023;329(16):1376-1385. doi:10.1001/jama.2023.4221).

Time frame

Within 3 months

Sponsors and contacts

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Shanghai 6th People's Hospital

Lead sponsor

Tsinghua University

Collaborator

Shanghai Jiao Tong University School of Medicine

Collaborator

Source ClinicalTrials.gov

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