Augmenting Insufficiently Accruing Oncology Clinical Trials Using Generative Models: Validation Study

Insufficient patient accrual is a major challenge in clinical trials and can result in underpowered studies, as well as exposing study participants to toxicity and additional costs, with limited scientific benefit. Real-world data can provide external controls, but insufficient accrual affects all arms of a study, not just controls. Studies that used generative models to simulate more patients were limited in the accrual scenarios considered, replicability criteria, number of generative models, and number of clinical trials evaluated.