RWD SIG

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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.

Let's T@lk Real Corner

This corner is created to discuss Real World Data (RWD) topics coming from industry, academia and Health Authorities.

Blog Posts:

Let's T@lk Real: Federated Data 9th December 2024

Let's T@lk Real: Immortal Time Bias and Time Zero 22 April 2024

Let's T@lk Real: DAGs 5th December 2023

Let's T@lk Real: What are RWD 3rd July 2023

Let's T@lk Real: External Controls 22nd May 2023

Let's T@lk Real: Survey 19th December 2022

 

Who we are

SIG MemberOrganisation
Antonio Remiro-AzocarNovo Nordisk
Deepak ParasharWarwick University
Eleanor Ralphs (Co-chair)IQVIA
Elizabeth MerrallJanssen
Fiona GrimsonUCB
Federica BelmonteNovo Nordisk
Helen BroadhurstPlus-Project
Jixian (Jason) WangBristol Myers Squibb
Josie Wolfram (Co-chair)Astellas
Laura DayAdaptimmune
Louise LinsellVisible Analytics Limited
Min-Hua JenEli Lilly
Orlando DoehringGSK
Rachel ThamAstellas
Rima Izem Novartis
Thomas DebraySmart Data Analysis and Statistics B.V.
Victoria StraussBoehringer Ingelheim

 

We also have an observer/informed member list who are included on meeting invites and mails, but we don’t expect active contributions nor list you on the SIG page members list. Shifting status to active is then welcomed any time!

Call for members

If you are interesting in joining the RWD SIG or would like to change your PSI RWD SIG membership status, please use the sign up form.

Frequency of Meetings

Monthly teleconferences

 

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