223 citations · 251 across the 9 of their papers we have counts for
3 papers · 1 filter
Regulatory Considerations for Using Artificial Intelligence Models to Reduce Sample Sizes in Registrational Studies
Aaron M. Smith, Tala Fakhouri, Run Zhuang +1
Applications of artificial intelligence (AI) in drug development continue to increase at a rapid pace. Regulatory authorities have provided increasingly clear perspectives on the u…
FRESH: Information-Geometric Calibration of Patient-Level Models to Aggregate Evidence
Franklin Fuller, Daniele Bertolini, Samantha Liang +2
This note introduces FRESH (Fusion of Recent Evidence and Subject Histories), a method for incorporating population-level summary results -- published clinical trials, registry sum…
Digital Twins as Synthetic Controls in Single-Arm Trials
Daniele Bertolini, Franklin Fuller, Aaron M. Smith +2
Single-arm trials are an important study design for evaluating drug efficacy and safety without enrolling patients into a control arm. Although they do not provide the gold-standar…