Date: 9 Oct 14.30-15.30 CET
The Covid-19 pandemic underscores the need for high-quality health data that is readily deployed. Europe’s early epidemiological assessments at the start of the pandemic projected infection and mortality rates by orders of magnitude in error. Once the pandemic was in full swing, official statistics in most European countries underreported coronavirus-related deaths. More recently, the retraction of two separate clinical studies for hydroxychloroquine published in two top medical journals due to unreliable primary data collection and meta-analysis demonstrated the importance of data quality for assessing vitally needed medicines. This session will offer distinct perspectives on how to address data problems such as these in the future so as to steer health policy with clarity and minimize negative repercussions on health outcomes beyond the pandemic.
- Raquel Yotti, Director of National Health Institute Carlos III: A Spanish perspective
- Rafael Bengoa, Director of SI-Health and former health minister of the Basque Country: A Spanish perspective
- George Hripcsak, Observational Health Data Sciences and Informatics (OHDSI) network: A global perspective
- Xavier Kurz, European Medicines Agency (EMA): A regulatory perspective
- Dani Prieto-Alhambra, European Health Data and Evidence Network (EHDEN): A project perspective
Date: 22 Oct 14-15h CET
With the growing use of regulatory tools such as conditional approvals and breakthrough designations, the traditional bottleneck of regulatory approval is today seen as far less problematic than it was previously. However, the early assessment of new products is also increasingly accompanied by smaller datasets that are often extrapolated for outcomes and survival. This creates enormous challenges for Europe’s HTA bodies, which need to assess these new treatments based on limited quantities of long-term outcomes data. This session will explore how EHDEN can function as a platform to capture longer-term outcomes data and provide alternative reimbursement and assessment approaches to facilitate comparative effectiveness measures.
- Gӧzde Susuzlu Briggs, “Data Saves Lives” coordinator, European Patients Forum (EPF)
- Anja Schiel, Senior Advisor and Statistician for the Norwegian Medicines Agency (NoMA)
- Slaveyko Djambazov, MD, Founder and Managing Director of HTA Ltd., an HTA consultancy focused on Central and Eastern Europe
- Niklas Hedberg, European Network for Health Technology Assessment (EUnetHTA)
- Jacolyne Bouvy, National Institute for Health and Care Excellence (NICE)
Date: 28 Oct 15h30-16h30 CET
Science is leading us down the path of increasingly targeted medicines with accompanying advances in genomics and our ability to develop personalised therapies for patients. However, there are increasing challenges in the development of drugs for ever smaller populations since, by definition, the rarer a disease is, the fewer people there are with the disorder that can participate in clinical research. EHDEN and other GDPR-compliant data-sharing platforms provide an alternative approach to drug development that enables researchers to search millions of historical anonymous patient records to model different scenarios and “health personas”, and to accelerate the development of medicines currently not available to patients in need. This session will provide an overview of RCT-alternative approaches, as well as explore the potential application of machine learning within the clinical trials domain.
- Nigel Hughes, Janssen Research & Development, EHDEN project lead
- Peter Speyer, Novartis, ML/AI expert (tbc)
- Magda Chlebus, European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Kai Langel, Trials@Home WP TECH lead/ Janssen Research