Real-World Evidence 2 - Advanced Clinical Trial Designs
This advanced compact course explores innovative and complex clinical trial designs beyond traditional randomized controlled trials (RCTs). Tailored for PhD candidates, the course provides a deep dive into adaptive platform trials, basket and umbrella trials, Trials within Cohorts (TwiCs), modern approaches to cluster-randomized trials (including stepped-wedge), and pragmatic designs integrated in clinical practice. The focus is on the methodological concepts, regulatory considerations, and practical implementation.
Participants will learn how to critically assess and apply advanced trial designs to address challenges in modern clinical research. The course combines theoretical instruction with real-world examples and interactive group work to foster a strong understanding of design selection, operational feasibility, and statistical analysis.
Learning Objectives:
Understand the rationale and structure of advanced clinical trial designs
Examine master protocols: platform, basket, and umbrella trials
Gain insights into TwiCs, pragmatic and modern cluster trial designs and decision-making
Evaluate regulatory perspectives and ethical considerations
Apply design strategies to real-world clinical research scenarios
| Course language: | English |
| Duration: | 2 days / 2 x 4 h in the afternoons |
| Next Start: | June 11, 2026 |
| Workload and ECTS: | 15h of workload |
Thursdays, June 11 & 18, 2026
2 Afternoons (2 × 4 hours); 13:00 – 17:00
- Afternoon sessions with expert-led lectures, interactive discussions, group exercises, and pre-readings
- Case-based learning using examples from ongoing clinical research
15 hours of workload. This course can be combined with the course Real-World Evidence Compact or module 4 (Randomized Controlled Trials) from the EHRM course to obtain 1 ECTS.
If all requirements have been met, you will receive a certificate for 15 hours of workload.
To add this course to your academic record, please create a Learning Contract on MOnA (choosing your supervisor as the assessor and pass/fail as assessment) before the start day of the course and follow the instructions of your respective faculty.
This course is open for everyone who is interested exploring innovative and complex trial designs beyond RCTs. The course is specifically tailored for PhD students of the PhD subject Clinical Research and related disciplines enrolled at the University of Basel, Faculty of Medicine.
Moreover, PhD students of the other PhD subjects of the Faculty of Medicine (Biomedical Engineering, Biomedical Ethics, Medicines Development, Nursing Science, Public Health/ Epidemiology or Sport Science) are eligible to register for the course.
Prerequisites:
Solid understanding of conventional clinical trial methodology and biostatistics. Solid understanding can be obtained e.g., in the Real-World Evidence 1 - Compact Course for Clinical Researchers.
Minimum 8 and maximum 18 registered participants.
CHF 750*
The course fee includes course materials and provision during coffee/tea breaks.
*)The Department of Clinical Research (DKF) offers training grants for members of DKF research groups which result in a reduced fee of CHF 375. Please note, that training grants can only be offered to DKF clinical research group members, who are working at the group leaders’ local study center.
Limited free places available for PhD Students of all PhD subjects of the Medical Faculty of the University of Basel.
Cancellation of your registration is possible until 10 days before the course date. Cancellation thereafter or absence from the course will result in a cancelation fee of half the course fee.
Directors of Studies:
- Dr. Andrea Kiemen
Teaching Staff:
- Prof. Dr. Matthias Briel
- Dr. Dr. Alain Amstutz
- Dr. Johannes Schwenke
- Dr. Christof Schönenberger
Mareike Gräter
Training and Education
Department Clinical Research (DKF), University of Basel
c/o University Hospital Basel
Spitalstrasse 8/12
CH-4031 Basel
mareike.graeter@clutterusb.ch
Tel. +41 61 556 59 76
Please register here.
Registration deadline is May 15, 2026.
Medical Faculty of the University of Basel
University Hospital Basel
Department of Clinical Research
Spitalstr. 8
4031 Basel
Sitzungszimmer, raised ground floor (right)