ISSUE: 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. This issue panel explores whether such networks can provide meaningful RWE in regulatory, clinical and HTA contexts.

OVERVIEW: This issue panel will debate the value of using federated data networks for generating decision-grade RWE. Moderator Dalia Dawoud will open the session by briefly introducing the EHDEN network and how it is used to generate RWE. Dani Prieto-Alhambra will provide 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, focussing on research on the safety of hydroxychloroquine. Alex Asiimwe will describe 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. Alan Lamb will provide the perspective of an HTA agency by describing how RWE is currently used in decision-making at NICE. He will highlight some of the challenges encountered in an HTA use case utilising the EHDEN network and whether and how these might be addressed.

The three 10-minute presentations will be followed by panel/audience discussion. Polling questions will be administered to seek the audience’s views on whether federated networks can generate meaningful evidence in each of the contexts examined.