A Hybrid Design Incorporating External Data to Evaluate Dexamethasone Intracameral Drug Delivery Suspension for Post-Cataract Surgery Inflammation.

Abstract

Traditional randomized controlled trials (RCTs) face increasing challenges due to lengthy recruitment and high costs. Regulators have encouraged the use of external data and real-world evidence (RWE) to improve efficiency, yet adoption in confirmatory settings remains limited by concerns over heterogeneity and bias. We conducted a proof-of-concept study to assess the feasibility and regulatory value of a hybrid Bayesian borrowing design to support a Phase III RCT of Dexamethasone Intracameral Dr