Bachinger M, Jankowski MA, Kesselheim AS, Krüger N - JAMA Network Open
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Summary:
Real-world evidence (RWE) was included in fewer than 10% of European Medicines Agency (EMA) drug approval documents from 2020 to 2023, with inconsistent reporting in how RWE was defined and presented. in drug approval decisions from 2020 to 2023. Standardized assessment tools are needed to better incorporate RWE in regulatory decision-making.
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