Analysis Group announced the publication of research examining the US Food and Drug Administration's (FDA's) commentary on the use of real-world evidence (RWE) in successful oncology product approvals between 2015 and 2020.
A team of researchers from Analysis Group, Pfizer, and the Dana-Farber Cancer Institute analyzed 133 original and 573 supplemental oncology new drug application and biologics license application approvals to identify the attributes of a successful RWE study that contributes to an accelerated or full drug approval.
Drug developers may prepare stronger submission dossiers for RWE studies by drawing on the research's key insights:
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