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This editorial discusses enhancements in drug development and risk assessment utilizing real-world data and evidence, suggesting improved decision-making processes.
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
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Yamazaki et al. (2026) studied this question.
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