In recent years, real-world evidence (RWE) has gained increased attention as a complement to traditional clinical trials to support the approval of supplementary indications or fulfill post-approval study requirements for drugs. However, until now, the possible use of RWE to establish the efficacy of oncology drugs for Food and Drug Administration (FDA) approval has not been described.
A significant precedent exists for the FDA’s acceptance of RWE, including the use of data from electronic health records, claims, post-marketing safety reports, retrospective medical record reviews, and expanded access studies in order to support oncology drug approvals, especially for rare or orphan indications.
In a recent article published in the Value in Health Journal, experts from Cardinal Health Specialty Solutions share how RWE can help bridge the gap between the constraints of the trial setting and the realities of clinical practice. Included are five key examples of where RWE was submitted in support of FDA approvals of original or supplementary indications for oncology drugs.
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