What will it take for RWE to become decision-grade? Sessions on the agenda at ISPOR Europe 2026
As real-world evidence (RWE) becomes increasingly embedded in healthcare decision-making, the focus is shifting from whether it should be used to what makes it sufficiently robust, relevant and fit-for-purpose. Ahead of ISPOR Europe 2026, we highlight sessions exploring what it takes to move RWE from available evidence to decision-grade evidence.
RWE continues to move closer to the center of health economics and outcomes research (HEOR). Earlier this year, ISPOR—The Professional Society for Health Economics and Outcomes Research ranked RWE as the second most important trend in its 2026–2027 Top 10 HEOR Trends report, reflecting its expanding role across regulatory, health technology assessment (HTA), payer and policy decision-making.
Developments across many regulatory and HTA bodies throughout 2026 have reinforced that direction. Canada’s Drug Agency issued guidance on AI-generated RWE for HTA, while the MHRA’s 2030 Strategy set out plans to expand the use of RWE alongside AI and wider regulatory reform. In the US, an FDA reorganization created dedicated divisions for AI and RWE analytics, further reflecting the growing institutional focus on how these evidence sources and analytical approaches can support regulatory decision-making.
This prominence is reflected throughout the program at ISPOR Europe 2026, taking place in Vienna, Austria, from November 8–11, 2026. Across the meeting, sessions will examine how RWE is generated, assessed and used, and what is needed for it to provide evidence that decision-makers can rely on.
What will the sessions on RWE focus on at ISPOR Europe 2026?
As the use of RWE expands, the conversation is becoming more demanding. The question is increasingly not simply where RWE can contribute, but what determines whether it is sufficiently credible, relevant and methodologically robust to influence decisions in practice.
Across the program, speakers will examine what makes real-world data fit-for-purpose, how causal inference and study design can strengthen confidence in findings, and what is required for RWE to meet the needs of HTA and reimbursement bodies. Other sessions consider pragmatic trials, federated data, European policy and data infrastructure, and the growing use of AI and natural language processing to generate evidence from routine care.
These discussions all point to a more mature phase for RWE, in which its value will increasingly depend not simply on the availability of real-world data, but on whether the resulting evidence is fit for the decision it is intended to inform. So, what will it take for RWE to become truly decision-grade?
For those heading to Vienna, we have selected sessions from across the program that explore the data, methods and evidence standards that could help answer that question.
Selected sessions
Patient-Reported Outcomes in Federated Real-World Data: Infrastructure Ready, Evidence Fit for HTA?
Date and time: Monday November 9, 2026, 10:30am – 11:30am
Moderator: Uwe Siebert (UMIT TIROL – University for Health Sciences and Technology; Harvard Chan School of Public Health)
Speakers: Angela Jane Rylands, Anke-Peggy Holtorf, Katia Verhamme and Mario Lawes (Data4Life)
One JCA, Many Decisions: Building an Evidence Strategy for Portability Across Europe
Date and time: Monday November 9, 2026, 11:45am – 12:15pm
Moderator: Martin Parkinson (Thermo Fisher Scientific)
Speakers: Carla Dias Barbosa (Thermo Fisher Scientific), Victoria F Paly (Takeda Oncology) and Caoimhe T Rice (Thermo Fisher Scientific)
Let’s Get REAL: Real-World Evidence in Action
Date and time: Monday November 9, 2026, 12:00pm – 12:30pm
Moderator: Denise Juliano (Premier Applied Sciences)
Speakers: Caroline Ryan (Teleflex), Lasair O'Callaghan (Sanofi), Didier Morel (Becton Dickinson) and Alexander de Groot (Intuitive Surgical)
The Future of Causal Inference: How Large (or Small) Role Will AI Play?
Date and time: Monday November 9, 2026, 1:45pm – 2:45pm
Moderator: Radek Wasiak (Adigens Health Limited)
Speakers: Miguel Hernan, Gorana Capkun and Michael Haft (Xplain Data)
Beyond “Using RWE”: What It Takes to Make Real-World Evidence Decision-Grade for HTA?
Date and time: Monday November 9, 2026, 4:45pm – 5:45pm
Moderator: Mark Sculpher (University of York)
Speakers: Tina Wang (CIRS), Huajie Jin (King's College London) and Jing Wu (Tianjin University)
Date and time: Tuesday November 10, 2026, 10:30am – 11:30am
Moderator: Dawn Lee (University of Exeter PenTAG)
Speakers: Michael Kolovetsios (Johnson & Johnson MedTech), Stacey Chang-Douglass (Clarivate) and Anastasia Chalkidou
Real-World Evidence Poster Tour
Date and time: Tuesday November 10, 2026, 11:30am – 12:15pm
Moderator: Sandrine Bourguignon
Featured posters: Six studies exploring how RWE is being generated and applied across patient engagement, obesity, screening, neurological and rare disease research, and HTA.
From Narrative to Evidence: How NLP-Extracted Clinical Facts Strengthen Real-World Research
Date and time: Tuesday November 10, 2026, 12:00pm – 12:30pm
Moderator: Jeffrey Brown (TriNetX)
Are New EU Policies Really Going to Improve RWD Availability to Inform Access Decisions?
Date and time: Tuesday November 10, 2026, 12:15pm – 1:15pm
Moderator: Sandipan Bhattacharjee (Bayer US LLC)
Speakers: Niklas Hedberg (TLV), Nienke Schutte and Alexander Natz (EUCOPE)
From Routine Care to Decision-Grade Evidence: Scaling Pragmatic Trials Across Health Systems
Date and time: Tuesday November 10, 2026, 3:15pm – 3:45pm
Speakers: Bruce Feinberg (Cardinal Health) and Nicholas Lazarou (Cardinal Health)
Biases that Generate Immortal Time: A Structural Diagnosis and Practical Solutions for HTA Submissions
Date and time: Wednesday November 11, 2026, 8:00am – 9:00am
Moderator: Miguel Hernán (Harvard T.H. Chan School of Public Health)
Speakers: Xabier Garcia de Albeniz (Adigens), Thibaut Sanglier (F.Hoffmann-La Roche) and Julia Vila (RTI Health Solutions)
From Static to Dynamic Value: Can Living HTA and AI Reshape the Innovation Cycle?
Date and time: Wednesday November 11, 2026, 8:00am – 9:00am
Moderator: Esther Nzenza
Speakers: Olivia Wu (University of Glasgow), Nicholas Adlard (Novartis Pharma) and Sabine Vogler (Gesundheit Österreich GmbH)
Coverage of ISPOR Europe 2026 by The Evidence Base
Our editorial team will be attending some of these key sessions, where we’ll be sharing key insights in our daily round-ups published at the end of each day of the conference. Follow The Evidence Base on LinkedIn for live updates throughout the meeting. And for exclusive post-event analysis and session round-ups, register on our site to receive regular updates.
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