EHDEN Partners Lead Issue Panel at ISPOR 2021: Using Federated Networks to Generate RWE: Why not now?’

EHDEN Partners, NICE, University of Oxford and Bayer presented an issues panel at the ISPOR 2021 meeting on 30th November to a broad audience on the subject of, ‘Using Federated Networks to Generate RWE: Why not now?’.

Evidence from observational studies has always been available to complement evidence from randomised clinical trials. However, recent advances in technology mean that such studies can be carried out on a large scale and cover a wide range of outcomes. This has resulted in lively debate on the place of RWE and its relevance to healthcare decision‑making. One approach to analysing real-world data is exemplified by the European Health Data and Evidence Network (EHDEN), a federated data network which includes data from across Europe which is standardised to a common data model. The panel explored whether such networks can provide meaningful RWE in regulatory, clinical and HTA contexts.

Dalia Dawoud, Senior Scientific Adviser, NICE, stated, “The use of federated data networks like EHDEN’s has a huge potential to standardise RWD analysis and overcome concerns related to data privacy and governance issues that HTA bodies and regulators are concerned about. Raising awareness of this added value amongst these key stakeholders is, thus, a very important starting point to ensure adoption of their use to generate evidence relevant for decision-making.”


Left to right: Dalia Dawoud (Senior Scientific Adviser, NICE), Daniel Prieto-Alhambra (University of Oxford, EHDEN Research Coordinator), Alan Lamb (Scientific Adviser, NICE), Alex Asiimwe (Head of Open Innovation Partnerships, Bayer).

The panel debated the value of using federated data networks for generating decision-grade RWE. Moderator Dalia Dawoud opened the session by briefly introducing the EHDEN network and how it is used to generate RWE. Dani Prieto-Alhambra provided supporting evidence that shows how a federated data network has been used to respond in a timely way to regulatory COVID-19 epidemic evidence needs, focusing on research on the safety of hydroxychloroquine (see news story here).

Alex Asiimwe described how federated data networks can provide evidence to guide clinical practice, highlighting a use case that investigated the natural history and outcomes of prostate cancer patients managed by watchful waiting from the IMI PIONEER project. Alan Lamb provided the perspective of an HTA agency by describing how RWE is currently used in decision-making at NICE. He highlighted some of the challenges encountered in an HTA use case utilising the EHDEN network and whether and how these might be addressed (see PharmacoEconomics paper here too).

In summing up the panel discussion, Prof Daniel Prieto-Alhambra, University of Oxford, suggested, “we see an expansion of RWE generation, based on the wider standardisation of RWD, standardised analytic tools, and methodological developments to meet an explosion of research questions, inclusive of in Health Technology Assessment, accelerated also by COVID-19, and we’re responding to this with EHDEN.”

The slide presentation from this panel discussion is here.