Menu Back to Short-Course-2-Aggregate-Safety-Assessments

Overview

*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

This Short Course will be offering in a virtual format only


This (mainly) formula-free half-day course will introduce a systematic approach for evaluating and assessing adverse events and other safety information, guided by medical judgment, which enables investigators to develop clinical as well as statistical understanding of the safety profile.

Topics to be covered include:

  • Denominators and numerators, variability, confidence intervals, p-values, and significance
  • Absolute risk, risk ratios, odds ratios, and hazard ratios – when, why, and what to look for
  • Safety estimands
  • Common abuses of statistics in PV
  • Quantitative frameworks for measuring evidence of association
  • A multidisciplinary approach that incorporates quantitative methods with clinical judgment
  • Scientific evaluation of accumulating program-level safety information throughout drug development

Learning objectives

At the conclusion of this session, participants should be able to:
  • Identify denominators and numerators, variability, confidence intervals, p-values, and significance
  • Describe how to interpret measures of risk: risk ratios, odds ratios, and hazard ratios – when, why, and what to look for
  • Describe how the new concept of estimands can be applied to safety analyses
  • Recognize common abuses of statistics in PV
  • Compare accumulating safety data combined across multiple studies
  • Leverage the scientific expertise and medical judgment of multidisciplinary teams
  • Develop and communicate the safety story