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

UID: 49

Author(s): Peter Doshi*, O'Mareen Spence, Aida Kuzucan, John H. Powers, III * Corresponding Author
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.
2011 - 2017
Subject Domain
Access Restrictions
Unrestricted access
Access Instructions
Available to download from the Zenodo site
Associated Publications
Data Type
Software Used
Google Docs
Google Sheets
Microsoft Excel
Microsoft Word
Study Type
Dataset Format(s)
PDF, Spreadsheet
Dataset Size
270.5 MB (Data Sources); 323.1 KB (Extraction Sheet)