Highlights from the SIGMA Symposium at the 2024 ISPE Annual Meeting

28 August 2024

The SIGMA-sponsored symposium at the 2024 ISPE Annual Meeting in Berlin was a remarkable event that brought together leading experts in pharmacoepidemiology and real-world evidence (RWE) generation. The symposium, titled "Target Trial Emulation with Real World Evidence: Regulatory Grade Pharmacoepidemiology in the SIGMA consortium," featured several insightful presentations and discussions on various topics related to pharmacoepidemiology and RWE.

The symposium began with an introduction from Ulrike Haug from the Leibniz Institute for Prevention Research and Epidemiology (BIPS) in Germany. This was followed by a presentation from Juan José Abellán from the European Medicines Agency (EMA) in the Netherlands, discussing the agency's interest in novel methods like the target trial emulation framework.

Buket Öztürk Esen from Aarhus University in Denmark and Vanessa Didelez from BIPS elaborated on the evaluation of treatment interventions that are sustained over time. They highlighted the implications of considering a healthcare intervention as a single-time exposure versus an exposure that is sustained over time.

David Martinez from RTI Health Solutions in Spain, presented a case study showcasing the application of target trial emulation in evaluating the safety of a cancer drug. This was followed by a session on technical solutions to deal with computational and statistical challenges, presented by Rosa Gini from the Agenzia regionale di sanità della Toscana (ARS) in Italy and Oisin Ryan from the University Medical Centre Utrecht (UMCU) in the Netherlands.

The symposium concluded with a discussion chaired by Ulrike Haug, featuring Vera Ehrenstein from Aarhus University, Xabier Garcia de Albeniz from RTI Health Solutions, and Jessica Young from Karolinska Institutet in Sweden. The discussion provided valuable insights into the challenges and opportunities in applying the target trial emulation framework in regulatory-grade pharmacoepidemiology studies.

Overall, the SIGMA-led symposium at the 2024 ISPE Annual Meeting was a highly informative and engaging event that showcased the latest advancements in pharmacoepidemiology and RWE generation. The presentations and discussions provided valuable insights and fostered collaboration among experts in the field.

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