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The Use of Observational Health‐Care Data to Identify and Report on Off‐Label Use of Biopharmaceutical Products
Author(s) -
Morris J
Publication year - 2012
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2012.30
Subject(s) - observational study , biopharmaceutical , leverage (statistics) , clinical pharmacology , business , risk analysis (engineering) , medicine , data science , computer science , pharmacology , microbiology and biotechnology , machine learning , biology
Significant efforts are under way to develop analytic surveillance systems that can leverage observational health‐care data to monitor biopharmaceutical products. The systems are being designed to identify safety‐related events in a postapproval setting, when the products are already on the market. An additional application of such a system would be the use of observational data to help identify and track off‐label use of marketed biopharmaceutical products in specific populations. The opportunities and challenges associated with such a system, as well as the underlying data sources themselves, are reviewed in this article. Clinical Pharmacology & Therapeutics (2012); 91 5, 937–942. doi: 10.1038/clpt.2012.30