PTI - international

• Recognize the consequences of allowing bias
• Identify sources of bias and variability
• Describe methods to reduce bias (e.g., randomizing, blinding, stratifying)
• Define Treatment-by-Strata Interaction

Exercise: Control for Potential Sources of Error

VI. Prepare a Protocol that Reflects Statistical Design Objectives

• Ensure protocol adheres to study objectives
• Identify study population inclusion and exclusion criteria
• Examine selection of study variables
• Pinpoint any patient subgroups of particular interest
• Detail your statistical methods section

Exercise: Outline the Protocol

VII. Develop a Statistical Analysis Plan

• Outline contents of a statistical analysis plan
  • study design
  • clinical objective
  • statistical objective – including sample size requirements
  • data derivation rules
  • analysis subset definitions
  • general statistical methodology
  • specific statistical methodology

VIII. Explore How Study Data are Examined Statistically

• Examine common tests used in statistical analysis (Chi squared,T tests,ANOVA methods, time to event)
• Investigate parametric vs. non-parametric analysis
• Recognize the difference between clinical and statistical significance
• Monitor expected outcomes (survival times, time to progression, rate of response)
• Assess baseline/demographic data
• Determine how to handle outlier data and data from questionable sites
• Ensure statistical data are ready for use in study reports

Exercise: Analyze a Sample Data Set

IX. Explore Additional Topics in Clinical Statistics

• Define relationship to clinical data management
• Identify statistical role before, during and after study
• Examine the ICH guideline E9 statistical principles for clinical trials
• Explain how statistical analysis differs for quality of life studies
• Introduce meta analysis

Discussion: Interactive Question and Answer Period