From Phase I (published in Statistics in Biopharmaceutical Research [SBR]):
- Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment
- The Current Landscape in Biostatistics of Real-World Data and Evidence: Clinical Study Design and Analysis
- The Current Landscape in Biostatistics of Real-World Data and Evidence: Causal Inference Frameworks for Study Design and Analysis.
From Phase II:
- Team 1: Estimands in Real-World Evidence Studies – Under review
- Team 2: Statistical Consideration for Fit-For-Use Real-World Data to Support Regulatory Decision Making in Drug Development – Forthcoming in SBR
- Team 3: Examples of Applying Causal Inference Roadmap to RWE Clinical Studies – Under revision