A Guide To In Silico Modeling And Simulation

Regulatory agencies typically require that a sponsor conduct a randomized controlled trial, with the control group being either a placebo, an active control, or a control arm using the standard of care. However, there are situations where a placebo control can be considered unethical or where neither an active control nor standard of care exists. In these scenarios, potential solutions include constructing a historical control arm using real-world data (RWD) or using an in silico method to construct a virtual patient control arm.

In in silico trials, investigational drugs are tested in virtual patients using sophisticated computational modeling and simulation techniques. When it comes to evaluating drug candidates prior to testing in humans or serving as an external synthetic control arm in single-arm prospective human trials, an in silico approach could be a viable option.

Learn more about how silico trials meet ethical codes and can be used to assess study participants.