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ISPOR Europe 2023 - Medaffcon

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Team Medaffcon took part of at ISPOR Europe 2023

The ISPOR Europe conference in 2023, held in Copenhagen, gathered a record number of participants. The Bella Center hosted HEOR professionals eager to learn about the latest trends in their field. The use of real world evidence (RWE) in health technology assessment (HTA) and regulatory evidence generation played a crucial role in the conference program, alongside valuable interpersonal interactions which were also in an important part of the event. 

 The ISPOR event was rich in content and attendance. The audience gathered in large numbers for the Monday morning welcome session, opened by ISPOR President Brian O’Rouke. O’Rourke noted that the ISPOR conference in Atlanta in May was the largest up to that point, but the European ISPOR surpassed it with over 5,600 participants, setting a record. 

Finland took the spotlight in the conference’s first plenary session, where experts from different countries discussed the European Health Data Space (EHDS). The strengths of Finnish real-world data (RWD) were highlighted in the speech by Markus Kalliola, a project director at Sitra. 

The idea of one platform containing information from multiple countries and sources was deemed valuable for RWE studies.However, the establishment of EHDS faces challenges. Those are related to data privacy, cultural challenges, and countries readiness to join the platform. 

The merging of multiple data sources was also discussed concerning external control arms in a panel moderated by Chris Cameron from Eversana Life Science Services. External control arms are becoming increasingly important when randomized and controlled clinical trials are not feasible. 

While external control arms are absolutely at the cutting edge in HTA and regulatory decision-making, specific rules or guidelines do not exist for their use. Thus, a variety of data sources, endpoints, and methods are employed. 

The audience of the panel discussion leaned toward combining multiple data sources, although panelists emphasized the importance of having one high-quality data source for external control arms. The key is ensuring that the data is of sufficient quality and collected from the country where it is being utilized. 

Throughout the conference, presentations showcased examples where RWD had been utilized in HTA and regulatory decision-making. Most of the examples presented had a positive outcome at the end of the negotiation. However, there was a desire for more examples. 

The conference days were so filled with information that attendees had little time to explore Copenhagen’s attractions. Nevertheless, children received souvenirs, the latest from the airport’s LEGO store. 

Real-world data and real-world evidence:

1. Utilizing RWD in Health Technology Assessment (HTA) and regulatory decision making 

2. External control arms are a hot topic in HTA and regulatory 

3. More examples of leveraging RWD are needed 

Harmonization of European practices: 

1. European Health Data Space; a platform containing information from multiple countries and sources 

2. EU joint clinical assessment (EU HTA)  

3. Standardizing the collection and analysis of RWD by creating guidelines 

Read more about Virtual Control Arms.

Blog post: Liisa Ukkola-Vuoti, Sr. Scientific Advisor
Video: Milla Kalliokoski, Marketing Manager
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