Requirements of Phase IV Trials vs. Phase III Trials

What happens after a drug reaches the market? Phase IV trials – also known as Real-World Evidence (RWE) studies – reveal how treatments perform in everyday practice, beyond the controlled setting of earlier phases.

In this course, you’ll discover the key differences between Phase III and Phase IV studies, explore real-world case studies, and learn how to turn RWE insights into real impact for patients and healthcare systems.

What's included?

• Documents and materials related to this course are included
• Globally recognised certificates awarded after test completion

Course schedule

Course Description

Phase IV trials, or Real-World Evidence (RWE) studies, provide essential insights into how medicines perform outside the controlled setting of Phase III trials. They highlight effectiveness, safety, and patient outcomes in routine practice, making them increasingly important for both regulators and healthcare decision-makers.

In this focused 2-hour session, you will:

• Understand the purpose of Phase IV studies and how they differ from earlier phases.

• Explore the main methods of collecting real-world data, such as registries and electronic health records.

• Review practical examples of Phase IV trials, learning from both successes and challenges.

• Discuss the implications of RWE for your own role and projects.

By the end, you will have a clear overview of where Phase IV fits into the clinical research landscape and how to approach these studies with greater confidence.