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.
Timeframe: 2011 - 2017

Subject Domain

Keywords

Access via Zenodo
Access Restrictions: Unrestricted access
Access Instructions: Available to download from the Zenodo site
Associated Publications: Doshi P, Spence O, Kuzucan A, Powers J. (2019). Communication of Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone: Cohort Study of FDA and Sponsor Communication, 2011-2017. JAMA Internal Medicine, March 4, 2019. DOI: 10.1001/jamainternmed.2018.7040
Data Type: Administrative
Software Used: Google Docs
Google Docs is a word processor included as part of a free, web-based software office suite offered by Google

Google Sheets
Online spreadsheet app that lets users create and format spreadsheets and simultaneously work with other people

Microsoft Excel
Spreadsheet software

Microsoft Word
Word processing software
Study Type: Observational
Dataset Format(s): PDF, Spreadsheet
Dataset Size: 270.5 MB (Data Sources); 323.1 KB (Extraction Sheet)

UMB Data Catalog

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