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Statistical Considerations When Developing Antibacterial Treatments
Session Chair(s)
Rima Izem, PhD
Associate Director Statistical Methodology
Novartis, Switzerland
Statistical Considerations When Feasibility of Traditionally Sized Trials Is an Issue
Learning Objective : Explain the challenges of performing a traditional development program for uncommon pathogens; Describe alternative approaches using the totality of data; Identify statistical challenges and innovative approaches to interpret data from smaller clinical programs, with strengths and limitations.
Speaker(s)
Challenges in Design and Analyses of Antibacterial Trials in the Face of Resistance
Scott Evans, PhD, MS
George Washington University Milken Institute of Public Health, United States
Professor and Founding Chair, Department of Biostatistics and Bioinformatics
Statistical Considerations When Feasibility of Traditionally Sized Trials Is an Issue
Aaron L. Dane, MS
AstraZeneca, United Kingdom
Biometrics & Information Sciences Infection Head
FDA Perspective
Daniel B. Rubin, PhD
FDA, United States
Statistician, Office of Translational Science, CDER
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