UMB Dataset
Dataset for Communicating Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone
UID: 49
- 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
Access
- Restrictions
-
Unrestricted access
- Instructions
- Available to download from the Zenodo site
Observational