Use of real-world data for drug development

Abstract

The use of real-world data (RWD) and real-world evidence (RWE) is an international trend in the modern healthcare system. In a review article, the authors highlight the use of RWD/RWE for drug development in the following categories: drug-drug interactions; dose selection in special populations such as patients with elimination organ dysfunction; dosing optimization in children; the use of quantitative clinical pharmacology in model-based drug development; use of RWE as a parallel data source to complement a randomized controlled trial to extend indications; RWD/RWE to create an external control group for rare diseases.