Newsletter April 2025

Dear Subscriber,

Welcome to the latest edition of the Real4Reg newsletter! In this issue, we highlight our partner University of Eastern Finland, featuring an insightful discussion on supportive frameworks for the generation of real-world evidence from real-world data.

Additionally, this edition features a recap of key events in 2024, highlighting the participation of Real4Reg partners, as well as insights from the MetReal cluster Multi-Stakeholder Workshop on RWD in regulatory/HTA decision-making, which took place in Bonn on February 6 this year. Be sure to explore these topics in our news section!

Supportive frameworks for generation of real-world evidence from real-world data

The importance of real-world evidence (RWE) derived from different real-world data (RWD) has been increasingly recognised, including its use in regulatory decision-making. Electronic health records, national registers and claims data are commonly utilised data sources, providing excellent opportunities for capturing the routine delivery of healthcare together with medication use and associated outcomes in representative real-life populations. As these data have typically been originally collected for other purposes than research, their application to RWE generation should involve fit-for-purpose assessment and appropriate formulation of study design. We highlight two frameworks that can support these crucial steps on the path from RWD to RWE. One of them, the Data Quality Framework is still evolving and thus not yet readily applicable for quality assessment, while the Target Trial Emulation Framework is already applicable and widely used.

Partner presentation: University of Eastern Finland (UEF)

The University of Eastern Finland (UEF) is a multidisciplinary university located on two campuses and employing 3200 staff members. The School of Pharmacy is located at the Kuopio campus, which is profiled on health sciences research. Research at the School of Pharmacy is focused on drug development but also covers the later stages of the product lifecycle. The objectives are to identify novel drugs, develop new targeted drug delivery technologies, and evaluate the utilisation, safety and effectiveness of drugs that are already on the market. Nearly half of the graduates in pharmacy in Finland graduate from UEF, and UEF is currently the only university in Finland offering a MSc-level course in pharmacoepidemiology. The School of Pharmacy also runs an international master’s degree programme in general toxicology.

Real-world evidence team

Professor Anna-Maija Tolppanen leads the Real-world evidence team at the School of Pharmacy UEF. In addition to her, the following researchers contribute to Real4Reg at UEF: clinical expert Prof em. Sirpa Hartikainen, pharmacoepidemiologist Anne Paakinaho, PhD (Pharm), clinical epidemiologist Blair Rajamaki, PhD, epidemiologist Thuan Vo MD, PhD, Kristina Kajba MSc (epidemiology) and bioinformatician Binu Mathew (MSc bioinformatics).

Tolppanen’s group develops, validates and implements methods and approaches for better use of routinely collected healthcare data in safety and effectiveness evaluation. The contributions have included use of machine learning methods in pharmacoepidemiology and risk prediction, as well as determining patient acceptable symptom state and minimum clinically important difference for patient-reported outcome measures. The group evaluates treatment patterns and associated outcomes in different therapeutic areas. It has contributed particularly to three areas: drug utilisation, adverse outcomes related to central nervous system-acting drugs, and health inequality in people with neurodegenerative disorders. These kinds of studies are necessary for understanding treatment patterns, their predictors and outcomes in real-life settings.

The studies conducted employ a whole range of data sources and include national register-based studies to multi- and single-site studies using data from hospital records and data collected specifically for research purposes. The research group is actively involved in national and international networks such as the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

Role in Real4Reg

UEF leads the post-authorisation use case work package, evaluating safety, effectiveness, and the impact of regulatory warnings on medication use. The goal of work package 2 is to prepare good practice examples for real-world data analysis with specific use cases related to fluoroquinolones (antibiotic medication) and SGLT2-inhibitors (oral diabetes medications which are also used to treat diastolic heart failure). In close collaboration with work package 3 and data providing partners, the work package improves methods for risk estimation in observational data and illustrates how the further development of methods and the application of new methodological approaches to different data sources can significantly help to inform regulatory decision-making in post-authorisation steps, as well as health technology assessment and reimbursement decisions. UEF also provides Finnish national data for the pre-authorisation use cases and is involved in data analyses, contextualisation and coordination.

UEF in media

News

Real4Reg position paper published in Health Research Policy and Systems

This article introduces the Real4Reg project, outlining its structure, objectives, and key contributions within the broader landscape of real-world data-focused European projects and initiatives.  

MetReal cluster - Multi-Stakeholder Workshop on RWD in regulatory/HTA decision making

On Thursday, 6 February 2025, the Multi-Stakeholder Workshop on Real-World Data (RWD) in regulatory and Health Technology Assessment (HTA) decision-making took place at BfArM, in Bonn, Germany. The gathering brought together key stakeholders from regulatory agencies, industry, academia, HTA bodies, and patient organisations. The event provided a platform to explore collaboration opportunities and share insights from six Horizon Europe-funded projects that make up the MetReal cluster.

Real4Reg Partners’ Participation in Key Events: a Brief Recap of 2024

As 2025 begins, it’s a good moment to look back at some of the key events that marked the Real4Reg journey in 2024. From important discussions to collaborative initiatives, the past year was full of activities and achievements.

Upcoming Events

13-16 May 2025, Montreal, Canada - ISPOR 2025
Read more

21-22 May 2025, Lisbon, Portugal - Real4Reg Consortium Meeting

3-6 June 2025, Turin, Italy - ENCALS 2025
Read more

For more information on additional events in the realms of real-world data, artificial intelligence, and health, please consult our Events page.

Follow Real4Reg on Social Media

RealReg is a project funded by the European Union under the Horizon Europe programme –Project No. 101095353. The consortium of ten European institutions aims to promote the use of real-world data to support regulatory decisions about medicines. For media inquiries, please contact: real4reg@infarmed.pt

Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Commission. Neither the European Union nor the granting authority can be held responsible for them.

Imprint

Federal Institute for Drugs and Medical Devices (BfArM)
Represented by the President
Prof. Dr Karl Broich

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Germany

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