Comparison of two assessments of real‐world data and real‐world evidence for regulatory decision‐making
Yuan L, Rahman M, Concato J. Comparison of two assessments of real‐world data and real‐world evidence for regulatory decision‐making. Clinical And Translational Science 2023, 17: e13702. PMID: 38093484, PMCID: PMC10766019, DOI: 10.1111/cts.13702.Peer-Reviewed Original ResearchReal-world evidenceEuropean Medicines AgencyDrug approvalOpen-label extension studyNon-interventional studySingle-arm trialClinical trial implementationUnited States FoodInterventional trialsComparator armDrug AdministrationMedicines AgencyExtension studyStudy designUse of RWEStates FoodPharmacovigilance activitiesTrialsRegulatory agenciesApprovalLack of agreementTrial implementationLiterature reviewTherapeutic contextReal-world data