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  • Reporting of Drug Benefit in FDA-Approved Prescription Drug Labeling
    UMB Dataset

    Authors
    Peter Doshi
    Bansri Desai
    Kyungwan Hong
    John H. Powers, III
    Description

    Clinicians prescribing therapeutic agents newly approved by the FDA must rely on the information reported through drug labels (also known as “package inserts”). Ideally, labels should incorporate details regarding key efficacy information, including the magnitude of treatment benefit, and measures of precision and random error (confidence intervals and p values). This study assessed the degree to which they actually provide this information. Original drug labels for all new molecular entities (NMEs) approved by the FDA between January 2015 and March 2018 were downloaded from the Drugs@FDA online database. NMEs not treating or preventing diseases or conditions and not tested in controlled trials were excluded. For each indication, the primary efficacy outcome was extracted and the presence or absence of the following attributes describing treatment effects were recorded: point estimates, confidence intervals, and p values. This dataset includes all data extracted and coded as well as copies of the original drug labels used in the study.

    Subject
    Drug Labeling/standards
    Access Rights
    Unrestricted access

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

    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. All FDA and sponsor nonefficacy benefit statements were extracted and categorized. Additionally, the IBM Micromedex Red Book was consulted for average unit prices for drug cost comparisons. The dataset includes all information sources for the NMEs as well as the noninferiority data extraction sheet.

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