Course description

There is an increasing interest in providing real world evidence for health care decision-making. Traditional randomized trials, also known as explanatory, often have characteristics that make them not useful to guide such decisions. This course introduces and deepens the concept of pragmatic trials to support decision-making in the real world.

The course is designed as a step-by-step guide providing an in-depth understanding of the historical foundations and philosophy of clinical trial conception and cutting-edge developments in pragmatic trial design. It will provide a solid understanding of how to design a clinical study that is most useful to inform decisions (pragmatic trial).

You will learn to make optimal design decisions and understand the implications of these choices, for example regarding selection of eligibility criteria, recruitment strategies, controls, adherence, measurement- and follow-up-intensity, choice of primary outcomes, and concepts of analytical approaches.

The course will also consider emerging technologies and routinely collected data that are increasingly shaping the future of randomized trial evidence generation.

The course aims to be highly interactive, intensive, and experiential. It targets those with an intention to conduct a randomized trial to inform medical decisions under real world conditions, soon or at some time in their future career.

Course structure

This course builds on the course "Real-World Evidence 1", but stands alone and can be attended without the previous knowledge.

This 3-week course requires students to:

1. complete weekly assignments (1-2 questions related to the specific topic of the week with reading prerequisites) and
2. attend a 4-hour in-person session per week

Course dates

Tuesdays, May 13, 20 and 27, 2025, 13.00 - 17.00h, Sitzungszimmer, raised ground floor, right, Spitalstr. 8, Basel

Target audience

Clinical researchers and PhD students enrolled at the University of Basel (Faculty of Medicine, Biomedical Engineering, Biomedical Ethics, Medicines Development, Nursing Science, Public Health/ Epidemiology or Sport Science) are eligible to register for the course. Please contact us if you are interested, but enrolled in another PhD programme. In general, all persons interested in these topics are welcome. 

Minimum 8 and maximum 15 registered participants.

Prerequisites for attending

Intention to conduct a randomized trial to inform medical decisions under real world conditions soon or at some time in the future career.

Basic theoretical or practical knowledge of randomized trial design is required, e.g., from an introductory course in epidemiology or from participation as a co-investigator in a completed, not necessarily pragmatic randomized trial.

Learning objectives:

Upon successful completion of this course, the students will be able to

1. Understand basic and advanced principles of pragmatic and explanatory trial designs
2. Critically assess the generalizability, applicability, and external validity of randomized clinical trials
3. Make optimal study design decisions and understand the implications of these choices for support of decision-making in the real world
4. Evaluate different research design options for testing treatment decisions under real world conditions in randomized trials.

Workload

• 20 hours of workload distributed over 3 weeks
• Written response to all weekly assignments related to the course content
• Active participation in weekly discussions
• Attendance to all sessions is required

Note for PhD students: The workload of this course will be tranfered into ECTS credits automatically if the course is listed in your approved learning agreement.

Assessment format

None

Study direction

PD Dr. med. Lars G Hemkens

Teaching staff

PD Dr. med. Lars G Hemkens
Lead Pragmatic Trials and Real World Evidence at RC2NB
Senior Scientist Department of Clinical Research

Perrine Janiaud, PhD
Clinical Researcher at RC2NB
Research Fellow at the Department of Clinical Research

Cathrine Axfors, MD PhD
Clinical Researcher
Pragmatic Evidence Lab RC2NB

Contact

Mareike Gräter
Training and Education, Department of Clinical Research

Costs

The course is free of charge.

Miscellaneous

Course language is English
Certificates will be issued after successful course completion

Registration

Please register here. Registration deadline is April 11, 2025.