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Overview

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This (mainly) formula-free half day course will provide a basic introduction to statistics and probability which will be applied in the context of drug safety. Topics to be covered include:

  • Understanding denominators and numerators
  • Measuring and presenting risk
  • Comparing risks: introduction to absolute risk, risk ratios, odds ratios, and hazard ratios – when, why, and what to look for
  • Understanding variability, confidence intervals, p-values, and significance
  • Meta-analysis vs. pooled analysis
  • Common statistics abuses in PV

Learning objectives

At the conclusion of this short course, participants should be able to:

  • Define and explain the significance of denominators and numerators
  • Discuss common approaches to measuring and presenting risk
  • Describe standard methods of comparing risks, including absolute risk, risk ratios, odds ratios, and hazard ratios – when, why, and what to look for
  • Explain the concepts of variability, confidence intervals, p-values, and significance
  • Compare Meta-analysis vs. pooled analysis
  • Recognize common statistics abuses in PV