Planning and Executing a Meta-analysis of Drug Safety: General Principles and Special Considerations
View Presentation *Mark Steven Levenson, FDA/CDER Keywords: meta-analysis, safety, sparseness In the last several years, FDA has used meta-analyses to address some important drug safety problems including antidepressants and suicidality, rosiglitazone and cardiovascular outcomes, and anti-epileptic drugs and suicidality. General meta-analysis principles and methodology are well established. However, in drug safety problems, special considerations arise. These considerations include, for example, the identification of events and the choice of appropriate methodology when events are sparse. Using recent FDA examples, this talk will both review the general meta-analysis principles and raise the special considerations of planning and executing a meta-analysis for drug safety problems.
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Key Dates
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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