Real-World Evidence & Data Integration for Clinical Trials

Wed, Aug 5, 10:30 AM - 12:20 PM Room CC-207 Thomas M. Menino Convention & Exhibition Center

Nairita GhosalChair

Biopharmaceutical Section

6 Presentations

Machine Learning–Generated Digital Twins as External Controls for Non-Randomized Trials

10:35 AM - 10:50 AM

Daniele Bertolini (Unlearn.AI)

Co-authors: Aaron Smith (Unlearn.AI), Franklin Fuller (Unlearn.AI), Jonathan Walsh (Unlearn.AI), Run Zhuang (Unlearn.AI)

Digital Twins External Controls Single Arm Trials Machine Learning Doubly Robust Estimators Oncology

Real-World Data as External Controls for Single-Arm Trials

10:50 AM - 11:05 AM

Kaili Ren (Takeda Development Center Americas, Inc.)

Co-authors: Kaili Ren (Takeda Development Center Americas, Inc.), Yu Yin (Takeda Development Center Americas, Inc.), Linyun Zhou (Takeda), Peter Yu (Takeda Development Center Americas, Inc.)

Real-world Data and Real-world Evidence External Control Study Indirect treatment comparison Inverse probability weighting Observational studies Comparative effectiveness

Covariate‑Adjusted Regularized Integration of Individual Patient‑Level Data

11:05 AM - 11:20 AM

Mohamad Hasan

Regularized Individual Patient‑Level Data Borrowing

Entropy-based information borrowing for hybrid analysis in real-world evidence supported studies

11:20 AM - 11:35 AM

Deepak Nag Ayyala (Takeda Pharmaceuticals)

Co-authors: Ananya Roy Chowdhury

information borrowing RWE/RWD entropy clinical trials rare diseases Bayesian modeling

Data Integration for Estimating Subgroup-Specific Conditional Average Treatment Effects (CATEs) Using Coarsened External Information in Randomized Trials

11:35 AM - 11:50 AM

Youqi Yang

Co-authors: Walter Dempsey, Bhramar Mukherjee (Yale University School of Public Health)

Data integration Conditional average treatment effect James-Stein Precision Medicine Empirical Bayes

Detection, Calibration and Adjustment of Unmeasured Confounding: Methodology and Implementation

11:50 AM - 12:05 PM

Hongwei Wang (AbbVie)

Co-authors: Weili He (AbbVie)

Real-world evidence Unmeasured confounding negative control proximal causal inference