Objectives Ambiguity in communication of key study parameters limits the utility of real-world
evidence (RWE) studies in healthcare decision-making. Clear communication about data …

Purpose Real‐world evidence (RWE) includes data from retrospective or prospective
observational studies and observational registries and provides insights beyond those …

Nonrandomized real‐world evidence (RWE) studies are conducted using healthcare data
collected as part of clinical practice. As RWE studies are increasingly considered for …

On December 8, 2016, the New England Journal of Medicine published a sounding board
on Real World Evidence (RWE) 1 by the US Food and Drug Administration (FDA) …

Turning real-world data (RWD) analyses into real-world evidence (RWE) requires accurate
estimation of causal treatment effects; to convince its critics, advocates of RWE will need to …

With the growing interest in using real-world evidence (RWE) for regulatory purposes,
researchers and policy makers are considering how best to assess the credibility of RWE …

The analysis of longitudinal healthcare data outside of highly controlled parallel‐group
randomized trials, termed real‐world evidence (RWE), has received increasing attention in …

Actionable real-world evidence (RWE) requires accurate estimation of causal treatment
effects. Calibration of RWE against randomized controlled trials (RCTs) is sometimes done …

To complement real‐world evidence (RWE) guidelines, the 2019 Structured Preapproval
and Postapproval Comparative study design framework to generate valid and transparent …

Recent legislation mandates that the US Food and Drug Administration issue guidance
regarding when real‐world evidence (RWE) could be used to support regulatory decision …