Use of Real-World Evidence to Support FDA Approval of Oncology Drugs

Real-world evidence (RWE) has gained increased attention in recent years as a complement to traditional clinical trials. The use of RWE to establish the efficacy of oncology drugs for Food and Drug Administration (FDA) approval has not been described. In this paper, we review 5 recent examples where...

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Veröffentlicht in:	Value in health 2020-10, Vol.23 (10), p.1358-1365
Hauptverfasser:	Feinberg, Bruce A., Gajra, Ajeet, Zettler, Marjorie E., Phillips, Todd D., Phillips, Eli G., Kish, Jonathan K.
Format:	Artikel
Sprache:	eng
Schlagworte:	Antineoplastic Agents - standards Antineoplastic Agents - therapeutic use Clinical medicine Clinical research Clinical trials Computerized medical records Data quality Drug Approval - methods Drug Approval - organization & administration Drug delivery systems Efficacy Electronic medical records Evidence-Based Practice - standards FDA approval Food and Drug Administration Health records Healthy food Humans Marketing Methodological problems Neoplasms - drug therapy Oncology oncology drug approval Pragmatic Clinical Trials as Topic - methods Pragmatic Clinical Trials as Topic - standards Prescription drugs real-world data real-world evidence United States United States Food and Drug Administration - standards
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