Safety Assessment with Observational Studies: Experiences at FDA/CDER

• Activity Number: 53
• Type: Invited
• Date/Time: Sunday, August 4, 2013 : 4:00 PM to 5:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Mark Steven Levenson*+
• Companies: Food and Drug Administration
• Keywords: drug safety ; epidemiology ; observational study

Abstract

The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration is making increased use of observational studies in the evaluation of adverse outcomes associated with drug products. Several large initiatives including the MiniSentinel and Federal Partners programs are designed for this purpose. The signal evaluation may be part of routine active surveillance or a dedicated effort to address a hypothesized drug and adverse outcome association. These studies present several methodological challenges both for statistics and epidemiology, including confounder adjustment and sequential design. This talk will review the use of safety assessment with observational studies at CDER and present several recent examples.