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In Silico Trials of Surgical Interventions

In Silico Trials of Surgical Interventions - Using Routinely Collected Data to Model Trial Feasibility and Design Efficiency In Vivo Randomised Controlled Trials

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05853536
Enrollment
13977257
Registered
2023-05-10
Start date
2019-08-01
Completion date
2024-08-01
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Brief summary

The project aims to establish a database of cardiovascular patients using HES and linked mortality data. This database will be used to model trials in silico with the aim of informing the design of future cardiovascular trials in the United Kingdom.

Detailed description

Routinely collected health data such as National Health Service Hospital Episode Statistics (HES) contains a wealth of real-world longitudinal patient health data including demographics, diagnoses, procedures and other clinical information. These data can be used to address many of the existing challenges in the design and conduct of clinical trials by optimising trial design and simplifying the assessment of adherence, safety, and outcomes. When a trial concept is initiated, researchers may use HES data to explore the hypothesis and assess trial feasibility. The large-volume patient data enables a detailed understanding of the characteristics of the target patient populations and the estimation of the real-world treatment effects across different patient groups thus enabling identification of targeted populations for specific interventions. By tapping into this resource and using advanced statistical and machine learning methods, the investigators can emulate the trial and thus obtain the key trial parameters required for designing a clinical trial, minimise the number of assumptions imputed and make the design and development of clinical trials quicker, simpler, and more reliable.

Interventions

None listed

Sponsors

King's College London
CollaboratorOTHER
University of Glasgow
CollaboratorOTHER
Cornell University
CollaboratorOTHER
Queen Mary University of London
CollaboratorOTHER
Newcastle University
CollaboratorOTHER
University of Bristol
CollaboratorOTHER
University of Leicester
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\- The target trial protocol will be used to develop an emulated trial protocol, which will give the best approximation of the trial protocol, given the limitations and constraints of the observational data. To mimic an actual trial population, the target trial population will be matched with individual patient data from a historical trial, targeting the same population.

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiovascular events (MACE) and their components1-YearAs specified in the trial protocol

Secondary

MeasureTime frameDescription
Adverse Events (Arrhythmias, Dialysis, Infection, Coronary Revascularization, Reintervention)1-YearAs specified in the trial protocol
Length of Hospital Stay1-YearAs specified in the trial protocol
Rehospitalisation1-YearAs specified in the trial protocol

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026