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
Further information: