Randomized Controlled Trials in Europe: A Call to Action to Protect National Healthcare Systems from the Upcoming Tsunami of Kidney Failure

Abstract

Kidney diseases are among the fastest-growing global health burdens, with chronic kidney disease projected to become the third leading cause of death by 2050. Despite this, therapeutic innovation remains limited: no European Medicines Agency-approved treatment exists for acute kidney injury, and no drugs have demonstrated survival benefits in patients on dialysis. Randomized controlled clinical trials, although pivotal for advancing care, face persistent challenges in nephrology, including patient heterogeneity, multimorbidity, high dropout rates and small populations in rare diseases. In Europe, these intrinsic obstacles are compounded by fragmented implementation of the Clinical Trials Regulation (536/2014), excessive safety reporting demands and lack of nephrology-specific guidance, discouraging academic-led initiatives and limiting pragmatic research. The Coalition for Reducing Bureaucracy in Clinical Trials, a broad alliance of medical societies and patient advocates, has recently published the 'Clinical research in Europe: putting quality and patient safety first' recommendations calling for regulatory harmonization, simplified safety reporting and patient-centred consent. The European Renal Association, a member of the Coalition and contributor to the report, fully supports these recommendations. Implementing such measures is critical to fostering efficient, high-quality nephrology trials in Europe and delivering urgently needed, evidence-based, life-saving and safe therapies for patients with kidney disease.