RWEdnesdays
Real-World Evidence, one Wednesday at a time.
A living repository of methods, operational nuances, and recurring dispatches on evidence that actually moves decisions.
Methods Catalog
Target Trial Emulation
Emulating a hypothetical randomized trial in observational data to reduce bias.
Proportion of Days Covered (PDC)
Preferred adherence measure for comparative studies; caps at 1.0 and handles overlapping fills via stockpiling rules.
Immortal Time Bias Handling
Bias from misaligned time-zero where "exposed" patients are guaranteed event-free time.
E-value Sensitivity Analysis
Minimum strength of unmeasured confounding needed to explain away an observed association.
New-User Design
Restrict to patients initiating treatment after a clean washout period to mimic trial eligibility.
Estimands (ATE/ATT + ICE Strategies)
ICH E9(R1) framework: define target population, treatment, summary measure, and intercurrent event handling.
RWEdnesdays
Concise, no-jargon takes on real-world evidence, AI in healthcare, and the messy reality of generating decision-grade evidence. Published (mostly) on Wednesdays.
The Rise of Foundation Models in Healthcare
How large-scale AI models are reshaping clinical decision support, drug discovery, and evidence generation — with real risks around hallucination and bias amplification.
FDA's Evolving Stance on Real-World Evidence
Recent guidance updates signal growing acceptance of RWE for label expansion and safety monitoring. What sponsors actually need to submit vs. what reviewers require.
Best Practices for EHR-Based Studies
Phenotype validation, data quality assessment, confounding control, and sensitivity analyses that strengthen causal claims from electronic health record data.