Real-World Evidence in Medicine Development

Overview

The course consists of 5 Learning Units, running over a period of approximately 8 weeks. Each Learning Unit requires 8-10 hours of student input. Please note that this course is designed for those with some familiarity with the development process for medicines. The course aims to give an overview of various concepts, approaches and techniques in real-world evidence generation. It is not designed to provide detailed training on specific methods (analytical techniques and study designs).

At the end of the course, you will be able to:

• Describe the medicine development chain and perspectives of various stakeholders on this chain

• Explain the factors that may affect the effectiveness of a new medicine in real life

• Explain existing designs for efficacy and effectiveness studies and how to evaluate those

• Explain the relationship between the study design choices of a relative effectiveness study and the value of information for marketing authorization at HTA

• Describe the operational challenges (including ethical, regulatory and legal aspects) of relative effectiveness studies

• Describe the existing current methods in evidence synthesis and the methods that can be applied for predictive medicine effectiveness modeling (incorporating real-world evidence)

• Understand how to integrate thinking about real-world evidence into medicine development and decision-making

• Communicate policy options around relative effectiveness, real-world evidence and various study designs

Accreditation

Real-World Evidence in Medicine Development was developed as part of the IMI GetReal project (2013-2017), and is offered by the UMC Utrecht on a non-profit basis.