Surya Chitra, PhD MBA Director Biostatistics Endo Health Solutions

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Presentation transcript:

Surya Chitra, PhD MBA Director Biostatistics Endo Health Solutions Noninferiority Trials in Drug Development: Clinical, Statistical and Regulatory Perspective Surya Chitra, PhD MBA Director Biostatistics Endo Health Solutions ……………………………………………………………..…………… AMS Endo Pharmaceuticals HealthTronics Qualitest

Industry Innovation & Growth Increasing trend in conducting Noninferiority trials in drug development will continue as more drugs are approved. Although this trend will make interpretation of trial results more challenging, it can provide opportunities for new outcomes for patients.

Learning Objectives Identity the crucial role of noninferiority trials in drug development. How to manage risk with noninferiority /superiority trials. Evaluate strategies for implementing noninferiority trials. Identify the challenges and opportunities with noninferiority trials Session Level = Intermediate

Agenda Wednesday, June 26, 2013 (4:00 PM – 5:30 PM) Start Time (Approx) Topic Speaker 4:05 PM Challenges Related to Noninferiority Tests: An Overview Yusong Chen, PhD 4:30 PM Noninferiority Margin Determination Using Dirichlet Process and Power Priors Ram Tiwari, PhD 4:55 PM Practical Experiences with Design and Analysis of Noninferiority Clinical Trials in Infectious Diseases Ulysses Diva, PhD 5:20 PM Q & A All