Real-World Evidence in Medicine Development

This interactive online course will give an understanding of current techniques, opportunities and challenges for the use of real-world evidence in medicine development. This is an ideal course for anyone who wishes to become familiar with key issues in the area of real-world data and wishes to broaden his/her expertise.

Course participants will come from pharmaceutical companies, regulatory authorities, health techonology assessment bodies, patients’ organisations, consultancy companies and academia. The course will foster discussion, interaction and mutual learning across all professionals involved in medicine development.

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).

Course Learning Units will cover the following topics:

Overview of the medicine development landscape
Real-world evidence generation
Real-world evidence synthesis
Decision-making and weighing of evidence
Demonstrating relative effectiveness to decision-makers

Quick Overview

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April 19, 2022

icon 8 weeks (8-10 hrs/week)

icon Basic level

icon 25 participants

icon English

icon Online including web lectures, individual and group assignments

icon Certificate of completion

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Course Fees

Standard

€2200

Government, university and non-profit Fee

€1100

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

Interactive online learning via the platform of Elevate Health
This self-paced online course is available through Elevate Health’s Virtual Learning Environment. The course is designed for interaction between teacher and participant and between participants. 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 as well as individual & group assignments and have the opportunity to connect with a key expert from the GetReal Academy for questions on the content and assignments in the course. You will learn through

The course has a set start date and will take 8 weeks to complete. The average workload for the course is 8-10 hours per week. During each week, participants will be able to study at their own pace and convenience. They are not required to attend the course at specific times, except when explicitly mentioned, such as for the closing webinar.

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 and choose which form of guidance works best.
• Interaction with an international peer group: learn, communicate and share knowledge with fellow students from around the world.
• Professional e-moderation: during your online learning journey, you will be guided by a professional moderator from Elevate Health.

Learning tools
This course consists of individual assignments such as web-lectures, interviews, computer practical, self-tests, as well as interactive assignments such as reading assignments, discussion assignments, collaboration assignments, peer feedback assignments.

Deadlines and Certificates

• Each LU will be spread over a period of 10 days to 2 weeks, including 1 or 2 weekends.
• A new LU will be made available on the first day of the specific period, and should be completed before the start of the next LU.
• A closing webinar will be organised, where participants will have the opportunity to interact with course staff and key experts from the GetReal Academy.
• 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.