Real-world studies have become increasingly important in providing evidence of treatment
effectiveness in clinical practice. While randomized clinical trials (RCTs) are the “gold …

Though randomized clinical trials (RCTs) are considered gold standard for establishing
efficacy;[2] in general, RCTs use a standardized therapy in a selected group of patients and …

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

Evidence from medication use in the real world setting can help to extrapolate and/or
augment data obtained in randomized controlled trials and establishes a broad picture of a …

Findings from clinical trials cannot be generalized to population at large due to the stringent
eligibility criteria. RWE studies complement clinical trials by generalizing the findings from …

While efficacy and safety data collected from randomized clinical trials are the evidentiary
standard for determining market authorization, this alone may no longer be sufficient to …

Regulators consider randomized controlled trials (RCTs) as the gold standard for evaluating
the safety and effectiveness of medications, but their costs, duration, and limited …

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 …

The vastness of clinical data and the progressing specialization of medical knowledge may
lead to misinterpretation of medication efficacy. To show a realistic perspective on drug …

The 21st Century Cures Act passed by the United States Congress mandates the US Food
and Drug Administration to develop guidance to evaluate the use of real‐world evidence …