Synthetic control arms and In silico clinical trials
The synthetic control arm is created by selecting a group of patients from historical data who have similar characteristics (e.g. demographics, disease stage, comorbidities) to the patients in the experimental group. The outcomes of the synthetic control group are then compared to the outcomes of the experimental group to assess the efficacy of the treatment.
Synthetic control arm can be used in various clinical trials such as in orphan drug development, rare disease, and in situations where it is difficult to find a suitable control group. However, it's important to note that synthetic control arm are not without limitations and the validity of the results obtained from this method should be carefully considered.This concept brings us closer to In silico trials – via simulating patients and using digital twins. Which can save us up to 75% of total costs of developing and commercializing a drug, let alone time constraints for recruitment and enrollment of patients.