Healthcare Data and Tools for Post-Market Drug Safety

• Activity Number: 4 - Safety Evaluation, Data Sources, and Statistical Strategies: Transforming Information into Evidence
• Type: Invited
• Date/Time: Sunday, July 30, 2017 : 2:00 PM to 3:50 PM
• Sponsor: ENAR
• Author(s): Mark Levenson*
• Companies: FDA

Abstract

Real-world data has always been an important source of information on the safety of marketed drugs. This has included mandatory and voluntary reporting of adverse events suspected of being drug related. In the past decade, the use of formal studies based on routinely collected data on medical encounters has been effectively used for drug safety evaluation. In 2016 the Sentinel System, a collaboration of health care data holders, was launched and greatly improved the efficiency of conducting observational studies of drug safety. Along with the new data sources, new tools and refinements of existing tools have taken place that are focused on the unique conditions encountered in drug safety evaluation. Moving forward such data may be used beyond drug safety and even form the basis of randomized controlled studies.