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

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