UMB Data Catalog

A project of the Health Sciences and Human Services Library
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Results Found: 2
  • 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
  • UMB Dataset

    Patient Consent to Publication and Data Sharing in Industry and NIH-Funded Clinical Trials

    Authors
    O'Mareen Spence
    Richie Onwuchekwa Uba
    Seongbin Shin
    Peter Doshi
    Description

    Clinical trial participants are often motivated by the altruistic assumption that study results will contribute to medical knowledge. Additionally, the sharing of research data is rapidly developing into an ethical standard. An evaluation of 144 blank (sample) informed consent forms (ICF) was undertaken to determine the extent to which clinical trial participants were apprised of researchers’ intent...

    Subject
    Informed Consent
    Access Rights
    Unrestricted access