Integration of Real-World Data into Clinical Trials: An Interdisciplinary Discussion from Regulatory and Practical Perspectives
Köppe, J.; Schiel, A.; Gerlinger, C.; Götte, H.; Edelmann, D.; Erdmann, S. · Das Gesundheitswesen · 2026 · Heft EFirst · S. 1 bis 1
Bibliografische Angaben
Zusammenfassung
Increasing efforts are required to integrate the growing volume of so-called real-world data (also named routine practice data), which are data generated outside of randomized controlled trials, into regulatory studies. Various stakeholders anticipate that such integration could save time and financial resources during the approval process of new therapies, and ethical considerations also partially support such an approach. The aim of this manuscript is to provide an overview of the methodological, ethical, and regulatory considerations when integrating routine practice data into randomized controlled trials. It…
