The use of evidence from clinical trials to support decisions for individual patients is a form of
“reference class forecasting”: implicit predictions for an individual are made on the basis of …

Abstract Real-world evidence (RWE), the understanding of treatment effectiveness in clinical
practice generated from longitudinal patient-level data from the routine operation of the …

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

Pharmacoepidemiologic and pharmacoeconomic analysis of health care databases has
become a vital source of evidence to support health care decision making and efficient …

Importance Clinical trials have identified numerous prescriptive predictors of mental disorder
treatment response, ie, predictors of which treatments are best for which patients. However …

Purpose For this article, the authors compiled, summarized, and analyzed data from 27
cases in which real-world data (RWD) were applied in regulatory approval. The aims were to …

Importance Manufacturers of US Food and Drug Administration–approved prescription
drugs often apply for additional indications based on randomized clinical trials. Real-world …

Randomized controlled trials (RCTs) form a cornerstone of oncology research by generating
evidence about the efficacy of therapies in selected patient populations. However, their …

Judicious use of real‐world data (RWD) is expected to make all steps in the development
and use of pharmaceuticals more effective and efficient, including research and …

Anaphylaxis is a severe hypersensitivity reaction that is rapid in onset and can result in
death. The pattern of an anaphylactic reaction can be uniphasic (or monophasic), biphasic …