WEBINAR: After the first JCA reports: How should comparative effectiveness be assessed? – January 27, 2027
The first Joint Clinical Assessments (JCA) under the EU HTA Regulation marks a new chapter in European pharmaceutical policy. JCAs require comparisons against many Member State-specific comparators, but randomized trials rarely cover them all. Furthermore, and current guidance focuses more on which evidence is acceptable than on how comparative effectiveness should be designed and judged.
In this audience-led session, Miguel Hernán, Huseyin Naci and Radek Wasiak discuss lessons from the first JCAs, where the target trial framework could help, and what developers and assessors need next.
Help shape the discussion by sharing the questions and challenges you would like the panel to address. Whether you are planning comparative evidence, preparing a JCA dossier or assessing study methods, your questions will help focus the session on the issues most relevant to your work.
| Submit your questions in advance here. |
What you will learn
- What the first JCAs tells us about comparative evidence gaps
- Why guidance on HOW to assess comparative effectiveness matters, not just which evidence is acceptable
- How the target trial framework can specify the causal question for each PICO
- What this means for evidence planning, dossiers and assessors
- What developers and HTA bodies should prioritize next
Speakers
Miguel Hernán
Kolokotrones Professor of Biostatistics and Epidemiology; Director, CAUSALab, Harvard T.H. Chan School of Public Health; co-founder, Adigens Health
Miguel Hernán is Kolokotrones Professor of Biostatistics and Epidemiology at the Harvard T.H. Chan School of Public Health, where he directs CAUSALab. His research develops and applies methods for causal inference from observational and randomized data, and he is a leading developer of the target trial framework for comparative effectiveness research. He is co-author of the textbook Causal Inference: What If. His work is widely used to inform clinical, regulatory and policy decisions.
Huseyin Naci
Professor, Department of Health Policy, London School of Economics and Political Science (LSE)
Huseyin Naci is a Professor in the Department of Health Policy at the LSE and a Lecturer in the Department of Population Medicine at the Harvard Medical School. He is the founder and Director of the Pharmaceutical Policy Lab and serves as one of the Deputy Directors of LSE Health.
Radek Wasiak
Co-founder, Managing Director, Adigens Health
Radek, an expert in real world data assets and generation and real-world evidence, has provided research services to life sciences for more than two decades. His research spans real-world data assessment, outcome measurement and their real-world data applications. He held research and executive roles at top consulting and clinical-research organizations, driving innovation and team growth.
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