Safety Assessment with Observational Studies: Experiences at FDA/CDER
*Mark Steven Levenson, CDER/FDA Keywords: propensity scores, safety, observational study The Center for Drug Evaluation and Research (CDER) 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 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. In particular, the use of propensity scores in studies will be highlighted and examined.
|
Key Dates
-
April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC