Editorial: Advancement of RWD/RWE utilization for enhancing drug development and benefit/risk assessment

Real-world data (RWD) and real-world evidence (RWE) have been utilized not only for drug safety assessment but also for effectiveness evaluation for drug approval on a global basis and many cases of RWD/RWE utilization for regulatory purposes have been accumulated with more diversifications in terms of data sources, methodology and study region (Kajiyama et al., 2024;Asano et al., 2025;Bachinger et al., 2025;Innes et al., 2025). Scientific discussions toward international harmonization related to RWD/RWE In conclusion, this research topic reflects a field of RWD/RWE utilization in transition from merely using RWD to actively strengthening RWE for decision-making use. The five studies provide a multifaceted view of the current state and emerging