Virtual Clinical Trial
In silico simulation of drug trials on digital patient populations
A virtual clinical trial (also called an in silico clinical trial) is a computational simulation that tests drug candidates on digital patient populations to predict efficacy, safety, optimal dosing, and responder subgroups before conducting human studies.
How Virtual Clinical Trials Work
Build Digital Patient Cohort
Create virtual patient populations from real-world multi-omics data, capturing disease heterogeneity and molecular variability.
Simulate Pharmacokinetics
Model drug absorption, distribution, metabolism, and excretion across the virtual population, accounting for genetic polymorphisms.
Model Pharmacodynamics
Simulate drug effects on disease pathways using systems biology models to predict target engagement and downstream effects.
Predict Clinical Endpoints
Generate predictions for response rates, progression-free survival, overall survival, and adverse event profiles.
Optimize Trial Design
Use simulation results to define patient selection criteria, dosing regimens, and trial endpoints for human studies.
Benefits of Virtual Clinical Trials
Cost Reduction
Phase III trials cost $50-100M+. Virtual trials cost a fraction, allowing more candidates to be tested and failed early before expensive human studies.
Faster Timelines
Virtual trials run in days to weeks vs. years for human trials. Rapid iteration enables testing of multiple dosing strategies and patient populations.
Better Patient Selection
Identify molecular biomarkers that predict response, enabling enrichment strategies that increase trial success rates.
Safety Signal Detection
Predict adverse events and toxicity before human exposure, eliminating dangerous candidates before they reach patients.
Regulatory Acceptance
Regulatory agencies increasingly accept in silico evidence as part of drug submissions:
- FDA:Model-Informed Drug Development (MIDD) program encourages simulation-based approaches. Multiple drugs approved with computational modeling data.
- EMA:Qualification of novel methodologies includes in silico approaches for specific contexts of use.
- ICH:Guidance on model-integrated evidence recognizes role of simulation in drug development.
Virtual Trials with Omic
Omic's digital patient platform enables pharmaceutical companies to run virtual clinical trials across thousands of patients in days rather than years.
Frequently Asked Questions
Can virtual trials replace human clinical trials?
Virtual trials cannot fully replace human trials but can significantly reduce their size, duration, and failure rate. They are used to optimize trial design, select patients, and de-risk programs before expensive human studies.
Are virtual clinical trials accepted by the FDA?
Yes. The FDA's Model-Informed Drug Development program encourages simulation-based approaches. Multiple drugs have been approved using computational modeling data as part of the evidence package.
How accurate are virtual clinical trial predictions?
Modern platforms achieve 85%+ accuracy in predicting drug response when validated against historical clinical trial data. Accuracy varies by disease area, endpoint, and quality of input data.