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 RWE was submitted in support of the FDA approvals of original or supplementary indications for oncology drugs.

Source: Value in Health - September 13, 2020 Category: International Medicine & Public Health Authors: Bruce A. Feinberg, Ajeet Gajra, Marjorie E. Zettler, Todd D. Phillips, Eli G. Phillips, Jonathan K. Kish Source Type: research