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  • Dataset (data extraction spreadsheet) of an Exploratory Review of Clinical Study Reports of Randomised Controlled Trials
    UMB Dataset

    Authors
    Peter Doshi
    Tom Jefferson
    Description

    This dataset (data extraction spreadsheet) is associated with an exploratory evaluation of pharmaceutical industry clinical study reports (CSR) for possible use in evidence synthesis and systematic reviews. 78 CSRs from public sources were selected for data extraction. The report dates range from 1991 through 2011, inclusive, and represent 90 randomized controlled trials of 14 pharmaceuticals. The primary outcome measures include presence and length of essential elements of trial design and reporting and compression factor (ratio of page length for CSRs compared to its published counterpart in a scientific journal). The dataset is comprised of an audited table of extracted and derived variables the details for which are described in an accompanying readme file. The uncorrected (original) and corrected extraction sheets as well as audit records are available upon request from Peter Doshi, corresponding author (pdoshi@rx.umaryland.edu).

    Subject
    Drug Industry
    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

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