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Innovative Designs for Cardiovascular Outcome Safety Trials in Type 2 Diabetes
Session Chair(s)
Cyrus R. Mehta, PhD, MSc
Founder and President
Cytel Inc., United States
This session presents strategies for designing adaptive trials that demonstrate cardiovascular safety of antidiabetic compounds.
Learning Objective : Discuss adaptive design through application to prominent recent clinical trials; Describe the scope, limitations and importance of the FDA Guidance to industry entitled "Diabetes Mellitus-Evaluating Cardiovascular Safety in New Antidiabetic Therapies to Treat Type-2 Diabetes"; Explain how cardiovascular outcomes are designed, monitored and conducted.
Speaker(s)
Clinical Development Approaches and Statistical Considerations to Assess the CV Safety of New Type 2 Diabetes Therapies
Rick Turner
DRT Strategies, Inc., United States
Expert Consultant
Meta-Analysis Approach to Establish Cardiovascular Safety: Experiences and New Suggestions
Stefan Hantel, PhD
Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany
Principal Statistician
Adaptive Designs to Demonstrate Risk Reduction in Cardiovascular Outcome Trials
Cyrus R. Mehta, PhD, MSc
Cytel Inc., United States
Founder and President
Panelist
Aloka Chakravarty, PhD
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
Director, Data Analytics
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