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Boston Convention and Exhibition Center

2013年6月23日 (日) 午前 8:30 - 2013年6月27日 (木) 午後 12:45

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Statistical Considerations When Developing Antibacterial Treatments

Session Chair(s)

Rima  Izem, PHD

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)

Scott  Evans, PHD, MS

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

Aaron L. Dane, MS

Statistical Considerations When Feasibility of Traditionally Sized Trials Is an Issue

Aaron L. Dane, MS

AstraZeneca, United Kingdom

Biometrics & Information Sciences Infection Head

Daniel B. Rubin, PHD

FDA Perspective

Daniel B. Rubin, PHD

FDA, United States

Statistician, Office of Translational Science, CDER

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