3 citations · 3 across the 1 of their papers we have counts for
3 papers
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…
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…
Enhancing Longitudinal Clinical Trial Efficiency with Digital Twins and Prognostic Covariate-Adjusted Mixed Models for Repeated Measures (PROCOVA-MMRM)
Jessica L. Ross, Arman Sabbaghi, Run Zhuang +7
Clinical trials are critical in advancing medical treatments but often suffer from immense time and financial burden. Advances in statistical methodologies and artificial intellige…