Randomized clinical trials: role of the research nurse

Abstract

Randomised clinical trials have transformed nephrology, driving major advances in the management of chronic kidney disease. Their success, however, depends not only on robust methodology but also on the professionals who deliver the protocols. This study aims to describe and critically discuss the role of the research nurse in randomized clinical trials in nephrology, highlighting their contribution to trial conduct, data quality, and patient engagement. Research nurses now play a critical and increasingly recognised role at the interface of science, clinical care and patient experience. Their responsibilities include guiding informed consent, ensuring adherence to Good Clinical Practice, coordinating complex study procedures, and maintaining high-quality data. Evidence from European nephrology trials, including ROTATE-3, FINESSE and other multicentre platforms, demonstrates that structured nursing involvement improves recruitment, retention and data integrity. Research nurses also contribute to protocol optimisation, feasibility assessments and scientific reporting, highlighting their evolution into true clinical research partners. Formal recognition, specialised training pathways and institutional support are essential to consolidate this role. Strengthening research nursing is a strategic priority to enhance trial efficiency and to advance kidney research across Europe. These findings position research nurses as key drivers of both operational efficiency and scientific quality in modern nephrology trials.