Statistical Challenges and Considerations in Drug Safety Evaluation
View Presentation *LaRee Ann Tracy, US Food and Drug Administration Keywords: Quantitative safety evaluation, risk benefit assessment, statistical considerations Drug safety evaluation is crucial in the understanding of a product’s risk to benefit profile; however, identifying a safety signal in pre-market clinical trials is often difficult if the event is rare and not systematically assessed. Similarily, designing large simple safety trials, product registries, or observational studies is often challenging due to sample size and time restrictions, lack of historical information, and a lack of validated measures or assays for the outcome measure. This session will discuss these challenges along with some recent examples of pre-and post-market safety study designs and analyses.
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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