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
2,113 already enrolled
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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
Details to know
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There are 4 modules in this course
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.
What's included
6 videos2 readings1 assignment
6 videos•Total 42 minutes
- Goals of effectiveness research•4 minutes
- Framing a research question•5 minutes
- Efficacy vs. effectiveness evidence•6 minutes
- Stakeholders who need evidence•5 minutes
- Real-world evidence for decision-making•13 minutes
- Choosing important outcomes•9 minutes
2 readings•Total 20 minutes
- Course Resources and Technical Support•10 minutes
- Principles of Drug Effectiveness Research•10 minutes
1 assignment•Total 30 minutes
- Module 1 Knowledge Check•30 minutes
What's included
4 videos1 reading1 assignment
4 videos•Total 61 minutes
- Trials versus Observational Designs for Causal Inference•10 minutes
- Cohort design including target trial emulation•24 minutes
- Case-control designs•10 minutes
- Self-controlled designs•17 minutes
1 reading•Total 10 minutes
- Methods in Drug Effectiveness Research – Part 1•10 minutes
1 assignment•Total 30 minutes
- Module 2 Knowledge Check•30 minutes
What's included
7 videos1 reading1 assignment
7 videos•Total 65 minutes
- Review of Some Common Biases•10 minutes
- Advantages of New User and Active Comparator Designs•13 minutes
- Immortal Time Bias•8 minutes
- Graphical depiction of study design•5 minutes
- Review of Confounding•3 minutes
- Regression with Propensity Score Methods•14 minutes
- Effectiveness Trials•12 minutes
1 reading•Total 10 minutes
- Methods in Drug Effectiveness Research – Part 2 •10 minutes
1 assignment•Total 30 minutes
- Module 3 Knowledge Check•30 minutes
What's included
2 videos2 readings1 assignment
2 videos•Total 33 minutes
- Comparative effectiveness study: Cohort study conducted like a trial emulation•18 minutes
- Comparative safety study: Self-controlled design•15 minutes
2 readings•Total 20 minutes
- Comparative Effectiveness and Real-World Evidence•10 minutes
- Closing Thoughts•10 minutes
1 assignment•Total 30 minutes
- Module 4 Knowledge Check•30 minutes
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