Real-World Evidence in Medicine Development

This self-paced online course gives an understanding of current techniques, opportunities and challenges for the creation of real-world data (RWD) to generate and use real-world evidence (RWE) for medicines in development. Course participants come from pharmaceutical companies, regulatory authorities, health technology assessment bodies, patients’ organisations, consultancy companies and academia.

The course consists of five self-paced chapters, addressing different aspects of RWD and RWE, and requires approximately 10-12 hours of input. This non-technical course is designed for those with some familiarity with medicines development and wish to broaden their expertise of this topic.

Course chapters will cover the following topics:

Introduction
The world of RWD and RWE
Generating and combining RWD
Using RWE in decision-making
Conclusion

This is an ideal course for anyone who wishes to become familiar with the various concepts, approaches and techniques of involved in generating and using RWD and RWE.

Quick Overview

Available now

icon 10-12 hours

icon Basic level

icon No limit on participants

icon English

icon Self-paced, online course

icon Certificate of completion

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Course Fees

Standard

€800

Government, university and non-profit Fee

€400

Member of the GetReal Institute: 25% discount on the fees
Group: 10% discount on the fees for the enrollment of 4 participants for non-GetReal Institute members

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Learning Objectives

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

For Whom?

• Participants distributed over the whole medicine development chain: from academic researchers and patients’ organisations to industry, regulatory and HTA professionals.
• No diplomas are required for enrollment, but the course is aimed at participants with some familiarity with biomedical research/medicines development.
• The course will be taught in English. To successfully participate, sufficient proficiency in reading and writing English is required.
• Sufficient time should be available. Based on prior experience with the course and feedback from participants, 8-10 hours should be allocated to the course each week. This level of intensity will make the course of most value to participants.

Learning Methods

Self-paced online learning via the platform of Elevate Health
This self-paced online course is available through Elevate Health’s Virtual Learning Environment. Participants will be guided by an e-moderator from Elevate, who will assist with any questions about online learning and the Virtual Learning Environment.

Participants will learn through web lectures, case studies as well as individual assignments and will have the opportunity to connect with a key expert from the GetReal Academy for questions on the content and assignments in the course.

The course can be started at any time and will need to be completed within 6 months. The average workload for the course is 10-12 hours per week. Participants will be able to study at their own pace and convenience and are not required to attend the course at specific times.

Advantages of an online course
• Flexibility and efficiency: there is no need to travel to attend a lecture, spend your time very efficiently.
• Personalised learning: study at your own pace.
• Professional assistance: during your online learning journey, you can seek guidance from a professional moderator from Elevate Health.

Learning tools
This course consists of individual assignments such as web-lectures, self-tests, as well as reading assignments and stimulating questions.

Deadlines and Certificates

There are no set deadlines in this course but the course needs to be completed within 6 months.

Participants will receive a certificate upon timely and successful completion of all assignments.

Course Staff

Pieter Stolk

UMCU

Pieter Stolk has been part of the project management team in IMI GetReal from the start in 2013, and was part of the team developing the Online RWEMD course. He has a background as a pharmacist, and has a PhD from the Division of Pharmacoepidemiology and Clinical Pharmacology at Utrecht University. He considers himself as a 'generalist', with a focus on topics around regulatory/HTA/policy issues around medicines development.
Mira Zuidgeest

UMCU

Mira Zuidgeest works as an assistant professor at the University Medical Center Utrecht (UMCU) and also part-time at the science driven clinical research organisation Julius Clinical, the Netherlands. She is a pharmacist by training with a master in epidemiology and a PhD in pharmacoepidemiology. She has a strong background in observational research, experience as health care provider in hospital pharmacy and a special interest in pediatric asthma, which led her to do a post-doc in Brazil. Her current work at the Julius Center focuses mainly on the topic of pragmatic trials and how to translate the concept of pragmatic trials to a methodologically sound and operationally feasible trial. As such, she is the scientific lead for the task force on pragmatic trials of the IMI GetReal Initiative. Combining the methodological work at the UMCU with the practice of clinical trial conduct at Julius Clinical provides her with a direct link between theory and practice.
Noemi Hummel

Certara Evidence & Access

Noemi has a background in biomathematics and statistics, with a great interest in modelling. Her experience in the biomedical field comes from both academia and industry. She works as a Senior Scientific Manager in a company consulting pharmaceutical companies and HTA. She holds a master in mathematics and a PhD in economics.
Mike Chambers

MC Healthcare Evaluation

Mike Chambers is Director of MC Healthcare Evaluation, which he set up in 2016 to provide advice on the generation of evidence of value of health technologies for healthcare payers. Until 2015 he was head of Value Demonstration and Reimbursement in Market Access at GSK, where he advised on emerging evidence requirements for reimbursement and local access to medicines, and developed innovative methods for communicating the value of GSK’s medicines to healthcare decision makers. He was previously Director of Health Economics in GSK R&D, where he led the respiratory therapy area health outcomes team. From 2001 to 2006 he established a health economics function (for diagnostic imaging) at Amersham Health/GE Healthcare. Mike has degrees in mathematical philosophy, demography and health economics and has also worked in the UK NHS, University of London, and HEOR consulting.