Validation Issues Could Dull Synthetic Data Benefits
Executive Summary
Is it real, or is it synthetic? When it comes to drug development data in the future, the answer could be the latter. Datasets that replicate the statistical patterns of real patient populations but carry no risk of privacy disclosures could enable the use of synthetic control arms. However, the biopharma industry and regulators will need assurance that these datasets accurately reflect the population from which they were derived.