
PSI/EFPSI RWD SIG - Focus for 2026
The PSI/EFPSI Real-World Data (RWD) Special Interest Group brings together statisticians, epidemiologists, clinicians, and regulatory scientists with a shared interest in the rigorous use of RWD across the drug development lifecycle.
Our Focus
In 2026, the SIG will focus on strengthening the interface between randomized clinical trials (RCTs) and real-world evidence (RWE). Members are particularly interested in how RWD can be used alongside, or in complement to, traditional trials to inform decision making in development, regulatory, and post marketing settings.
A key theme for the year is making RWD more accessible to clinical trialists. While trial statisticians are highly experienced in analytical methods, challenges often arise around understanding data provenance, patient inclusion mechanisms, time zero definitions, and the operational realities of real-world datasets. The SIG aims to support better cross-disciplinary understanding through practical discussion and shared learning.
Key Areas of Interest
The group’s interests for 2026 include:
- Integration of RCT and RWD approaches, including hybrid designs, external control arms, and data borrowing from real-world sources, external databases, or prior trials
- Terminology alignment and misconceptions, particularly where language differs between the clinical trial and RWD communities
- Study design and causal inference, including data source selection, covariate definition, and comparative analyses in postmarketing and rare disease settings
- Practical realities of working with RWD, such as differences in measurement frequency and context between RCTs and routine care, and the time and effort required to prepare RWD for analysis
- Use of RWD across the drug lifecycle, from candidate nomination and trial design to post approval evidence generation and understanding real-world use of treatments
Our Ambition
Beyond experience sharing, the SIG aims to contribute more broadly to the PSI community by:
- Highlighting low hanging opportunities where better use of RWD can add value
- Providing informed input when new guidance or consultation opportunities arise
- Supporting education and awareness around good practice with RWD
For 2026, SIG activities will aim to share the group’s expertise beyond the SIG itself.