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 both in the design and in the analysis of observational studies. We briefly address pragmatic trials as a source of effectiveness and safety information. The course concludes with examples of published studies illustrating good practices.
Pillar #3: Drug Effectiveness - Real-World Evidence
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Pillar #3: Drug Effectiveness - Real-World Evidence
This course is part of Drug Development and Pharmacoepidemiology Specialization
Instructor: Jodi Segal
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13 reviews
6 hours to complete
Flexible schedule
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What you'll learn
Differentiate efficacy and effectiveness research and identify stakeholders who value this research in public health and regulatory decision-making.
Recognize the strengths and limitations of epidemiology study designs, including cohort, case-control, case-cohort, and self-controlled designs.
Use best methods of study design and analysis to control for confounding and biases in observational research
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Assessments
4 assignments
Taught in English
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This course is part of the Drug Development and Pharmacoepidemiology Specialization
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Johns Hopkins University
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Reviewed on Dec 17, 2025
Good with content however they might have taken more examples.
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