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  • UMB Dataset

    Dataset for Communicating Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone

    Authors
    Peter Doshi
    O'Mareen Spence
    Aida Kuzucan
    John H. Powers, III
    Description

    This dataset is the result of an investigation characterizing nonefficacy benefits of newly approved molecular entities (NMEs) based exclusively on noninferiority trials. Qualifying NMEs were identified using the FDA’s Novel Drug Approval website, sponsor press releases at market entry, FDA Drug Trials Snapshots, and statistical and medical officer reports. A total of 18 were selected for analysis....

    Subject
    Drug Industry
    Equivalence Trials as Topic
    Human Experimentation/ethics
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access