Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control arms

Randomized clinical trials (RCTs) are the gold standard in producing clinical evidence of efficacy and safety of medical interventions. More recently, a new paradigm is emerging—specifically within the context of preauthorization regulatory decision‐making—for some novel uses of real‐world evidence...

Ausführliche Beschreibung

Bibliographische Detailangaben

Veröffentlicht in:	Pharmacoepidemiology and drug safety 2020-10, Vol.29 (10), p.1228-1235
Hauptverfasser:	Burcu, Mehmet, Dreyer, Nancy A., Franklin, Jessica M., Blum, Michael D., Critchlow, Cathy W., Perfetto, Eleanor M., Zhou, Wei
Format:	Artikel
Sprache:	eng
Schlagworte:	Clinical trials Decision making external controls historical controls Original Report Original Reports pharmacoepidemiology Rare diseases real‐world data real‐world evidence regulatory decision‐making
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!