UMB Data Catalog
A project of the Health Sciences and Human Services Library-
Dataset for Communicating Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone
UMB Dataset- Authors
- Peter DoshiO'Mareen SpenceAida KuzucanJohn 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
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Drug IndustryEquivalence Trials as TopicHuman Experimentation/ethicsUnited States. Food and Drug Administration
- Access Rights
- Unrestricted access