FUNDED PROJECTS
TriaLearn
TrialLearn – developing a training module for clinical researchers to use and generate real world evidence
Category: Incubator Grant
University:
University of Bern, University of Galway, Uppsala University
Period:
2025-2027
With the increasing digitalization of health care and growing emphasis on real-world evidence to inform clinical and regulatory decision-making across European healthcare systems, training in Real World Evidence (RWE) remains fragmented, methodologically inconsistent, and often inaccessible to clinician-researchers who seek to apply these approaches in practice. As healthcare systems across Europe navigate the integration of routinely collected data into evidence-based practice, there is an urgent need for high-quality training that prepares clinician researchers to design, interpret, and critically evaluate studies using these data sources. Without adequate training in real-world evidence and clinical trial methodology, researchers risk designing or interpreting studies that produce biased, non-generalizable, or clinically irrelevant findings, ultimately compromising the quality of evidence, used to inform patient care and health policy.
This project aims to develop an online module in Real World Evidence (RWE) to equip clinical researchers with basic skills to design and interpret trials using routinely collected data. The module will serve as the foundation for a broader educational platform in clinical trials methodology (TrialLearn), to be developed in collaboration with the University of Uppsala and University of Galway.
This online module will provide learners with a conceptual foundation in RWE and prepare them to leverage data from sources including electronic health records, administrative databases or registries into research and practice. This online module introduces clinical researchers to the principles and practical applications of RWE from RCD. It moves beyond passive learning by engaging participants in challenge-based, problem-solving activities grounded in real clinical research scenarios.
"My personal highlight of this project is its focus on bridging the gap between methodological rigor and real-world clinical practice through accessible, high-quality training in real-world evidence. By combining challenge-based learning, realistic clinical cases, and interactive formative assessment, the module moves beyond theory to equip clinician-researchers with practical decision-making skills. The collaborative development with European universities is particularly impactful, as it lays the foundation for a shared educational standard in RWE, fostering methodological alignment, cross-border collaboration, and ultimately improving the quality and relevance of evidence generated from routine care."
Participants and Stakeholders
The University of Bern will act as lead coordinator and be responsible for the development and implementation of the TrialLearn online platform, with a specific focus on the topic of decentralized trials;
The University of Galway and the University of Uppsala will contribute methodological expertise, support content review and enhancement, and lead dissemination and uptake of the platform within their institutions.
- Coordinator: University of Bern, Dr. Sharon Mitchell
The University of Bern, led by Dr. Sharon Mitchell, will coordinate the project and lead the development, pedagogical design, and implementation of the TrialLearn online platform.
- Other Partner Institutions: University of Galway, University of Uppsala
- Team Composition:
Dr. Sharon Mitchell, Department of Clinical Research, University of Bern
Prof. Dr. Lars Hemkens, Department of Clinical Research, University of Bern
Prof. Hemkens will serve as a content expert, overseeing the scientific rigor and methodological accuracy of the real-world evidence curriculum.
Dr. Perrine Janiaud, Department of Clinical Research, University of Bern
Dr. Janiaud will contribute domain expertise in clinical research methodology and support the development and review of course content and case-based materials.
Prof. Dr. Eva Segelov, Department of Clinical Research, University of Bern
Prof. Segelov will contribute clinical research expertise and ensure the relevance of course content to real-world clinical trial practice.
Prof. Declan Devane, College of Medicine, University of Galway
Prof. Devane will provide expertise in trial methodology and knowledge translation, review course content, and support dissemination at the University of Galway.
Prof. Shaun Treweek, Faculty of Medicine, University of Uppsala
Prof. Treweek will contribute expertise in trial design and methodological innovation, support the development of interactive learning components, and lead a review and dissemination activities at the University of Uppsala.
Objectives
Collaborating with other European universities through this initiative lays the groundwork for a shared educational standard in RWE, ensuring consistent and high-quality training across institutions. It aims to raise the practical competencies of researchers involved in clinical trials by promoting methodological alignment and improving the relevance of training to real-world challenges. The program creates a scalable education platform to raise quality and consistency of clinical research embedded in real-world care, while fostering cross-European collaboration and knowledge exchange.
Contact
Dr. Sharon Mitchell,
Additional information
This project is distinguished by its integration of rigorous real-world evidence methodology with innovative, challenge-based online learning grounded in authentic clinical research scenarios. Its cross-European collaboration creates a shared, scalable educational platform that promotes methodological consistency while directly equipping clinician-researchers to generate and critically appraise evidence embedded in routine care.