Drug Effectiveness and Real-World Evidence

This course addresses the key principles of research aimed at assessing the effectiveness and safety of pharmaceuticals. We begin by exploring the role of effectiveness research and stakeholders who need this evidence and explore the common observational designs that are used with real world data to generate real world evidence about safety, effectiveness and comparative effectiveness of drugs. We discuss confounders and biases that must be addressed and methods for overcoming these challenges b

• Differentiate efficacy and effectiveness research and identify stakeholders in public health decisions
• Recognize strengths and limitations of epidemiologic study designs including cohort and case-control
• Apply study design and analysis methods to control confounding and biases in observational research