Sequential Generalized Likelihood Ratio Tests for Safety Evaluation
View Presentation *Jie Chen, Merck Serono Keywords: Generalized likelihood ratio tests; rotavirus, sequential probability ratio test, safety boundaries The safety evaluation of pharmaceutical products involves pre-clinical animal studies, pre-licensure randomized clinical trials and post-approval safety surveillance. Sequential design and analysis are of particular interest because they allow early termination of the trial or quick detection that the product exceeds a prescribed bound on the adverse event rate. After a review of recent developments in this area, we propose a new class of sequential generalized likelihood ratio tests for evaluating adverse event rates in two-armed pre-licensure clinical trials and single- armed post-approval surveillance. The proposed approach is illustrated using data from the Rotavirus Efficacy and Safety Trial (REST). Simulation studies of the performance of the proposed approach and other methods are also given.
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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