Article ID Journal Published Year Pages File Type
7518649 Journal of Clinical Epidemiology 2018 26 Pages PDF
Abstract
Nonrandomized data were used for 7% of EMA drug approvals. Larger effect sizes were associated with greater likelihood of approval based on nonrandomized data alone. We did not find a clear treatment effect threshold for drug approval without RCT evidence.
Related Topics
Health Sciences Medicine and Dentistry Public Health and Health Policy
Authors
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