External Comparator Groups Derived from Real-world Data Used in Support of Regulatory Decision Making: Use Cases and Challenges

Abstract Real-world data (RWD) from electronic health records (EHRs) and administrative claims databases are used increasingly to generate real-world evidence (RWE). RWE is support clinical packages for medicines that inform decision-makers. In this review of current issues in the use RWD-derived external comparator groups regulatory filings, we assess a series topics generally apply across many disease indications. However, most examples illustrations focus on oncology research setting. The include an overview uses RWD drug development, discussion filings using comparators, brief guidance documents white papers pertaining summary some limitations methodological finally, look at future area recommendations.