Investigating the Role and Impact of ENCePP in an Evolving Real-World Data Landscape - A Qualitative Study

Abstract

Background: The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) was set up by the European Medicines Agency (EMA) in 2007, with the main aim of strengthening PE/PV research in Europe. In the last few years there have been significant developments in the PE/PV landscape, such as the increased use of Real-World Data (RWD) in PE/PV research and regulatory decision making, especially since the COVID-19 pandemic. Objective: To investigate the current and future role and impact of ENCePP in a fast-evolving RWD/RWE landscape. Methods: This was a qualitative study conducted between May – October 2024, consisting of a series of semi-structured interviews and a survey. Participants included relevant stakeholders from the PE/PV research field, with a mix of ENCePP Partners and non-Partners. The interviews covered opinions of and experiences with ENCePP overall, while the survey focused mainly on use of the ENCePP tools. The interviews were approximately 30 minutes long and were conducted via Microsoft Teams. They were transcribed verbatim using Amberscript and coded using NVivo. The survey consisted of 33 multiple-choice and open answer questions. It was created and distributed using Qualtrics, and the results were analysed using SPSS. Results: 18 interviews were conducted, and there were 52 complete responses to the survey. The results confirm the current role of ENCePP as a network, a source of guidance, a bridge between institutions, and as a pioneer in establishing common research standards. Many participants received a strong benefit from the use of the ENCePP Network and tools, though there were some barriers and areas for improvement identified. Suggestions for the future included ideas for new tools and new roles ENCePP could take on, as well as what its primary objective and positioning could be. Majority of participants emphasised increasing visibility, both within and outside of the European Union (EU), as an important focus area. Conclusion: The results of this study confirm that there are many who are invested in ENCePP’s progress and output. Through an in-depth analysis of the opinions and experiences of relevant stakeholders in the PE/PV research field, combined with an overview of how the tools are used, this study provides a strong foundation for the decisions ENCePP has to make regarding its future steps.