Methodology, Statistics and Operation of Pragmatic Trials (Coming Soon)

This self-paced course will provide an understanding of methodology, statistics and operation of pragmatic trials and concepts and impacts of Estimands, for the use of real-world evidence.

The course is intended for anyone who wishes to extend their knowledge on real-world evidence with a specific focus on multiple aspects of pragmatic trials. Participants are distributed over the whole medicine development chain: from academic researchers to industry, regulatory and other professionals.

This course consists of four self-paced learning units, starting with an introduction to real world evidence generation, followed by learning units on the methodology of pragmatic trials, an introduction to the statistics relevant to pragmatic trials and the operation of pragmatic trials. After the course participants are asked to complete a final quiz, with case examples to practice. The course takes on average 20 hours to complete.

An overview of the learning units of this course:

  • Methodology of Pragmatic Trials
  • Introduction to Statistics in Pragmatic Trials and Estimand Concept
  • Operation of Pragmatic Trials
  • Final Quiz

Quick Overview

icon Coming soon

icon 15-20 hours

icon Advanced level

icon No limit on participants

icon English

icon Self-paced, online course

icon Certificate of completion

Course Fees




Government, university and non-profit Fee

  • 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
Pre-register Now

Learning Objectives

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

  • Explain what Data Generation Methods exist of, what their benefits and limitations are and when/under what circumstances they can be applied.
  • Reflect upon the Design Options and possible Data Sources for Pragmatic Clinical Trials.
  • Develop a draft design for a Pragmatic Clinical Trial, utilizing existing tools, as a basis for discussion with trial teams.
  • Describe the main aspects of statistical analysis relevant to pragmatic trial data.
  • Explain the concepts of estimands.
  • Explain the impact of estimands on pragmatic trial design, endpoint selection and data analysis.
  • Understand the GetReal tool and it’s content.
  • Use the GetReal tool in a pragmatic trial and to identify operation challenges.
  • Interpret the results from the GetReal tool and discuss possible solutions for a pragmatic trial.


For Whom?

• Participants distributed over the whole medicine development chain:  from academic researchers to industry, regulatory and other professionals.
• No diplomas are required for enrollment, but the course is aimed at participants who have an advanced level of understanding of benefit-risk in drug development. Familiarity with regulatory science and medicines development is recommended.
• The course will be taught in English. To successfully participate, sufficient proficiency in English reading and writing is required.

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. Participants will learn from key experts of the GetReal Academy through web lectures, case studies, individual assignments and self-tests.

The course has no set start date and the workload is estimated to be approximately 15-20 hours. Participants can 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 and choose which form of guidance works best.
• Personal feedback on your final assignment from two experts.

Learning tools
This course consists of web lectures, case assignments, self-tests, stimulating questions and peer-feedback assignments.

Deadlines and Certificates

There are no set deadlines in this course. 

Participants will receive a certificate upon completion of all required learning activities and a score of 80% or higher in the final quiz. Access to the course in the online learning environment will be granted for unto 1 year after enrolment into the course.

CME accreditation for this course is currently under request.

Course Staff

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    Mira Zuidgeest
    Mira Zuidgeest works as an assistant professor at the University Medical Center Utrecht (UMCU) and also part-time at the science driven clinical research organization 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.
  • Other course staff: Thomas Kumke, Dr. D. (Daniel) Boateng, Robin Vernooij and Anna-Katherina Meinecke.