A workshop hosted by NICE in collaboration with GetReal Institute as part of IMI-EHDEN project
On Monday 31st October, NICE hosted a virtual workshop entitled ‘Regulators are formally adopting real world evidence, when will health technology assessment?’. It was organised as part of our work within the Innovative Medicines Initiative grant-funded project European Health Data & Evidence Network (EHDEN), in collaboration with GetReal Institute.
The half-day workshop, moderated by Dr Dalia Dawoud (Associate Director, Science Policy and Research Programme), aimed to provide an update on recent developments and progress towards greater use of real-world evidence (RWE) in regulatory decision making by the European Medicines Agency (EMA) and consider the implications and opportunities for European health technology assessment (HTA) agencies and their stakeholders.
Keynote speakers were invited to talk about the use of RWE in healthcare decision making from a variety of perspectives. In the first session, Juan José Abellán (Biostatistics and Real-World Evidence Senior Specialist, EMA) explained the EMA’s approach to RWE evidence, and Peter Rijnbeek (Professor of Medical Informatics and Chair of the Department of Medical Informatics, Erasmus Medical Centre, Netherlands) explained the role of the newly founded Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®). Reflections on this, and possible implications for HTA, were offered by Niklas Hedberg (Chair of the Consortium Executive Board, EUnetHTA21) and Páll Jónsson (Programme Director for Data and Real-World Evidence, NICE).
In the second session, we heard reflections from a variety of stakeholders about what more can be done to advance the adoption of RWE for HTA. Speakers represented industry (Hannah Goovaerts, Health Economics & Outcomes Research Manager, Pfizer), patients (Valentina Strammiello, Head of Programmes, European Patients’ Forum), academia and clinical (Andrew Morris, Director, Health Data Research UK), and non-profit organisations (Karen Facey, Facilitator, RWE4Decisions). In the third and final session, speakers from EHDEN (Nigel Hughes, Scientific Director, Janssen and Project Lead, IMI-EHDEN) and GetReal Institute (Shahid Hanif, Managing Director) presented how they can support the adoption of RWE in HTA, and considered what more can be done. Ravinder Claire (Senior Analyst, NICE) showcased 2 ‘case studies’ that NICE are leading within EHDEN, to demonstrate potential applications of RWE to HTA.
Each session was followed by a panel discussion where an engaged multidisciplinary audience of over 100 posed questions to speakers. The workshop stimulated strong discussion about the direction that HTA is headed in with regards to RWE. The audience felt that the generalisability of trial data and population characteristics, amongst others, were key evidence gaps for HTA that RWE could help to fill. It was also deemed that one of the ways initiatives like GetReal Institute and EHDEN should focus their support for HTA is by a multi-disciplinary approach to training and upskilling researchers and users of RWE.
- EHDEN is an Innovative Medicines Initiative-funded project that is establishing a federated network of healthcare databases in Europe conforming to the OMOP common data model. You can find out more here: https://www.ehden.eu/
- GetReal Institute is an independent, member-led, not-for-profit organisation, with a mission to facilitate the adoption and implementation of RWE in healthcare decision-making in Europe. You can find out more here: https://www.getreal-institute.org/
- You can find out about the other research NICE is involved in here: https://www.nice.org.uk/about/what-we-do/our-research-work/our-projects-and-partners