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Validation Issues Could Dull Synthetic Data Benefits

 
• By Sue Sutter

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.

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Synthetic datasets, which replicate the statistical patterns of real patient populations but carry no risk of privacy disclosures, are becoming part of the vernacular of the pharmaceutical development and real-world evidence landscape.

While the concept is not new, the breadth and seriousness of the COVID-19 pandemic has accelerated interest, with researchers, industry and regulators all looking for evidence that helps inform a...

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