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Pillar #3: Drug Effectiveness - Real-World Evidence

Pillar #3: Drug Effectiveness - Real-World Evidence

This course is part of Drug Development and Pharmacoepidemiology Specialization

Instructor: Jodi Segal

1,920 already enrolled

Included with

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4 modules

Gain insight into a topic and learn the fundamentals.

13 reviews

6 hours to complete

Flexible schedule

Learn at your own pace

4 modules

Gain insight into a topic and learn the fundamentals.

13 reviews

6 hours to complete

Flexible schedule

Learn at your own pace

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

Skills you'll gain

Details to know

Shareable certificate

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Assessments

4 assignments

Taught in English

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Build your subject-matter expertise

This course is part of the Drug Development and Pharmacoepidemiology Specialization

When you enroll in this course, you'll also be enrolled in this Specialization.

Learn new concepts from industry experts
Gain a foundational understanding of a subject or tool
Develop job-relevant skills with hands-on projects
Earn a shareable career certificate

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.

Module details

What's included

6 videos2 readings1 assignment

6 videosTotal 42 minutes

Goals of effectiveness research4 minutes
Framing a research question5 minutes
Efficacy vs. effectiveness evidence6 minutes
Stakeholders who need evidence5 minutes
Real-world evidence for decision-making13 minutes
Choosing important outcomes9 minutes

2 readingsTotal 20 minutes

Course Resources and Technical Support10 minutes
Principles of Drug Effectiveness Research10 minutes

1 assignmentTotal 30 minutes

Module 1 Knowledge Check30 minutes

What's included

4 videos1 reading1 assignment

What's included

7 videos1 reading1 assignment

7 videosTotal 65 minutes

Review of Some Common Biases10 minutes
Advantages of New User and Active Comparator Designs13 minutes
Immortal Time Bias8 minutes
Graphical depiction of study design5 minutes
Review of Confounding3 minutes
Regression with Propensity Score Methods14 minutes
Effectiveness Trials12 minutes

1 readingTotal 10 minutes

Methods in Drug Effectiveness Research – Part 2 10 minutes

1 assignmentTotal 30 minutes

Module 3 Knowledge Check30 minutes

What's included

2 videos2 readings1 assignment

Earn a career certificate

Add this credential to your LinkedIn profile, resume, or CV. Share it on social media and in your performance review.

Instructor

Jodi Segal

Johns Hopkins University

1 Course1,920 learners

Offered by

Johns Hopkins University

Pillar #3: Drug Effectiveness - Real-World Evidence

Pillar #3: Drug Effectiveness - Real-World Evidence

What you'll learn

Skills you'll gain

Details to know

See how employees at top companies are mastering in-demand skills

Build your subject-matter expertise

There are 4 modules in this course

Principles of Drug Effectiveness Research

What's included

Methods in Drug Effectiveness Research – Part 1

What's included

Methods in Drug Effectiveness Research – Part 2

What's included

Comparative Effectiveness and Real-World Evidence

What's included

Earn a career certificate

Instructor

Offered by

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Frequently asked questions

When will I have access to the lectures and assignments?

What will I get if I subscribe to this Specialization?

Is financial aid available?

More questions