GLGi: Biostatistics: Issues of Regulatory Interest

Time & Location

Originally Presented: March 7, 2007 7:30 AM, New York

Presenter(s):

GLG Expert Contributor

Agenda:

  • Regulatory Queries Regarding: - Censoring Post-Randomization Events - Accelerated and Regular Approval Topics - Biomarkers and Subgroups
  • Bias, Variability, and the Importance of Missing Data
  • Blinded vs Open Label Trials

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