All Times EDT
Keywords: External Control, Oncology Drug, Regulatory Review
An external control may be an option when the preferable randomized control is not feasible for estimating comparative treatment effect. The potential of external control has been actively discussed among FDA and industry to seek why, when and how to leverage rich external data sources to address the benefits, risks, and usage of medical products. Nevertheless, the use of these data sources (including RWD) should meet the established rigor and standards required for regulatory decisions.
In this talk, considerations for trial design, conduct, and analysis when including external control will be discussed. At last, a few examples of using external control data in hematology and oncology drug applications will be presented.