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.
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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
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.
Interactive online learning via the platform of Elevate Health
The online course is available through Elevate Health’s Virtual Learning Environment. The course is designed as a self-paced module. You can learn from GetReal top experts, through web lectures as well as individual assignments, case studies and self-tests.
The course has no set start date. The total average workload is around 20 hours. You will be able to study at your own pace and convenience. It is not required to participate in the course during specific moments of the day.
Advantages of an online course
• Flexibility and efficiency: there is no need to travel to attend a lecture, so you can spend your time very efficiently.
• Personalized learning: you can study at your own pace and choose which form of guidance works best for you.
• Personal feedback on your final assignment from multiple experts.
Learning tools
This course consists of weblectures, case assignments, self-tests, reading assignments and, stimulating questions.
Dr. M.G.P. (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.
Thomas Kumke
Dr. D. (Daniel) Boateng
Robin Vernooij
Anna-Katherina Meinecke
There are no set deadlines in this course.
You will receive a certificate upon completion of all required learning activities and a score of 80% or higher on the final examination quiz. Access to the course in the online learning environment will be granted for up to 1 year after enrollment into the course.
CME accreditation for this course is currently under request.
• 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 methodology, statistics, and operation of pragmatic trials. 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.
Fees
• Standard fee: €900
• Public sector: government, university and non-profit organizations: €450
• Members of the GetReal Institute: 25% discount
• Groups: 10% discount for the enrollment of 4 participants (non-GetReal members only)
Please contact us at info@elevatehealth.eu to request a discount code for the public sector fee (€450) and/or a member of the GetReal Institute or group 10% discount code.
We believe that future-proof research is essential for good care. That is why we combine innovative medical knowledge with didactics. Thanks to our extensive network and proven didactic methods, we make Life Sciences and Health professionals better than yesterday.
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