Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval

This cross-sectional study examines the feasibility of using real-world data, such as billing, claims, and electronic health records, to emulate US Food and Drug Administration-required confirmatory clinical trials for the 50 new therapeutic agents that received accelerated approval between 2009 and 2018.

Automated summary

This study aims to evaluate the feasibility of using real-world data to emulate confirmatory clinical trials for new therapeutic agents that received accelerated approval between 2009 and 2018.