This analysis explores the use of real-world evidence in regulatory decision-making, suggesting clearer standards to improve data quality and transparency.
Key Points Real‐World Evidence (RWE) application in regulatory decisions remains limited. Clear standards are needed for data quality, transparency, and acceptable study designs for the use of RWE in regulatory contexts. Registry certification system and research plan review system for RWE research would help reduce regulatory uncertainty. To balance data protection and research utility, relaxation of privacy protection regulations for designated government‐managed registries could be considered.
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Park et al. (2026) studied this question.
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