Meta-analysis Approach to Establish Cardiovascular Safety
View Presentation *Stefan Hantel, Boehringer Ingelheim Pharma GmbH & Co. KG Keywords: meta-analysis, According to the FDA guideline "Guidance for Industry Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes", the sponsor has to establish cardiovascular safety for a new antidiabetic drug by showing that the upper confidence limit of the hazard ratio (HR) for cardiovascular events of the new compound versus comparator(s) is below 1.8 at time of submission and to show that the upper confidence limit is below 1.3 after the approval. One approach to rule out the cardiovascular risk is to run a meta-analysis including trials, which are completed at time of submission and using interim data from still ongoing trials. This talk will illustrate how this can be achieved by a pre-defined meta-analysis of phase 2 and phase 3 clinical trials including in addition data from an ongoing cardiovascular outcome trial. The meta-analysis offers also the option to show cardiovascular safety based on the 1.3 non-inferiority margin or even superiority. The meta-analysis addresses also the multiplicity issue of repeated tests similar to a group-sequential design.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC