Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
7518649 | Journal of Clinical Epidemiology | 2018 | 26 Pages |
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.
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Authors
Benjamin Djulbegovic, Paul Glasziou, Farina A. Klocksieben, Tea Reljic, Magali VanDenBergh, Rahul Mhaskar, John P.A. Ioannidis, Iain Chalmers,