Research using Real World Data – Principles and Methodologies
This compact course introduces to the principles, methodologies, and applications of Real-World Evidence (RWE) in clinical research. Designed for PhD candidates, the course bridges the gap between traditional randomized controlled trials (RCTs) and the growing importance of real-world data (RWD) in regulatory decision-making, health technology assessment, and clinical practice.
Participants will explore the sources of RWD, including electronic health records, registries, claims data, and patient-reported outcomes. The course emphasizes methodological rigor, including study design, bias mitigation, and statistical approaches tailored to observational data. In addition, it will provide examples of how the use of RWD can make RCTs more efficient. Through interactive sessions, case studies, and group discussions, students will gain practical insights into how RWE can complement clinical trials and inform evidence-based medicine.
Learning Objectives:
- Understand the definition and scope of Real-World Evidence in clinical research
- Identify and evaluate different sources of Real-World Data
- Design robust RWE studies and understand common pitfalls
- Apply appropriate analytical methods to RWD
- Understand how RWD can support an efficient conduct of RCTs
| Course language: | English |
| Duration: | 2 days / 2 x 4 h in the afternoons |
| Next Start: | Spring 2027 |
| Workload in hours or ECTS: | 15h |
Thursdays, May 7 & 21, 2026
2 Afternoons (2 × 4 hours); 13:00 – 17:00
- Afternoon sessions with lectures, interactive discussions, hands-on group work, and pre-readings
- Case-based learning with real-world examples from clinical research
If all requirements have been met, you will receive a certificate for 15 hours of workload.
This course does not directly award ECTS. It can be combined to reach a workload of 25-30 hours, to receive 1 ECTS. To add the course to your academic record, create a Learning Contract (LC) in MOnA (choosing your supervisor as the assessor and pass/fail as assessment) before the start of the course.
This course is open for everyone who is interested building a foundational understanding of real-world evidence (RWE) in research. 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 GSMHS and 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:
Basic knowledge of clinical research methodology and statistics. Basic knowledge can be obtained e.g. in the Essentials in Health Research Methods (EHRM) courses.
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 (MD-)PhD Students of the GSMHS and of all (MD-)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.
Organiser
Department of Clinical Research, University of Basel, c/o University Hospital Basel
Director of Studies
Dr. Andrea Kiemen, Scientific Officer Training & Education, Department of Clinical Research (DKF)
Teaching Staff:
- Prof. Dr. Dr. Matthias Briel, Deputy Director, Basel Institute for Clinical Epidemiology & Biostatistics (CEB) and Head of the Meta-Research Center, Basel, DKF
- Alain Amstutz, MD PhD, Senior Research Associate, Department of Clinical Research (DKF)
- Dr. Johannes Schwenke, MD-PhD candidate, Department of Clinical Research (DKF)
- Dr. Christof Schönenberger, MD-PhD candidate, Department of Clinical Research (DKF)
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
The next course will be open for registration soon.
Medical Faculty of the University of Basel
University Hospital Basel, DKF, Seminarraum, raised ground floor (right), Spitalstrasse 12, 4031 Basel