Download Presentations
Welcome! Contact Kathleen Wert if you are experiencing difficulties accessing the presentations.
General Session I: The Agency's Critical Path Initiative and the Statistician's Role in Evaluating the Safety of New Drug Products
No presentations received
General Session II: Flexible Design: A Debate
Presentation A - Bayesian Adaptive Design & Interim Analysis - Donald Berry
General Session III: Non-inferiority Trials: What Are Our Experiences?
Presentation B - Non-Inferiority in Conformity Active Control Clinical Trials: Concepts and Statistical Methods - Gary Koch
General Session IV: Quantifying the Ratio of Risk and Benefit - no presentations received
Presentation B - Superior Safety in Noninferiority Trials- David R. Bristol
Parallel Sessions I - Gate-keeping Strategy, Co-primary Endpoints and Secondary Endpoints
Parallel Sessions II - Evolving Data Standards: Implications for Statistical Analysis and Review
Parallel Sessions III - Controls
Parallel Sessions IV - Missing Data: Are We Dealing With the Real Problem?
Parallel Sessions V - Advisory Committees and Regulatory Review
No presentations received
Parallel Sessions VI - Surrogate Markers in Drug Development
Parallel Sessions VII - Accelerating Drug Development Using Novel Experimental Designs and Analyses
Presentation A - A Practical Approach to Accelerating the Clinical Development Process - Jerald S. Schindler
Parallel Sessions VIII - Issues in Phase IV Post Marketing and Production
No presentations received
Parallel Sessions IX - FDA/Industry Symposium on Clinical Pharmacogenomics/Proteomics
No presentations received