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Early Automation of Data Mining at the FDA using Oracle Health Sciences Empirica Signal and Study

Early Automation of Data Mining at the FDA using Oracle Health Sciences Empirica Signal and Study

Since the early 1990s, the FDA has used data mining (the practice of examining large databases to generate new information) to gain a better understanding of adverse signals within clinical trial safety data. The agency has also advocated the use of data mining by the pharmaceutical industry when conducting clinical trials. Recently, the FDA has begun adding more sophisticated methods to its data mining activities and has applied these methods to other product-safety-related databases.

In an effort to define its data mining activities, the FDA has issued a white paper, Data Mining at FDA (Nov 2015). It provides an overview of its past and present data mining methods, the advantages/challenges of data mining and future directions for data mining at the FDA.

Dr. Sameer Thapar, Director, Global Pharmacovigilance (Oracle Health Sciences Consulting), and Assistant Professor, Drug Safety and Pharmacovigilance (Rutgers University), has studied this paper and offered highlights in a new Oracle Brief.  

Introduction by Barbara Rudolph, Senior Content Marketing Manager, Oracle


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