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An external control may be an option when the preferable randomized control is not feasible for estimating comparative treatment effect. Nevertheless, the use of data sources (including Real World Data), innovative statistical methods, and evidence derived from these innovative approaches should meet the established rigor and standards required for regulatory decisions.
In this talk, a few examples of using external control data in hematology and oncology drug applications will be examined and evaluated from a regulatory perspective. Also, considerations for trial design and analysis when including external control will be discussed.
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