Changing paradigms of studies in kidney diseases

Abstract

Recognizing kidney disease as a major global health issue, the International Society of Nephrology convened a 2-day international, multi-stakeholder meeting to develop a road map for advancing clinical research in nephrology. The meeting focused on promoting the use of patient-reported outcome measures, moving beyond single biomarker targets, adopting innovative trial designs, and incorporating hierarchical composite end points. Participants included clinicians, trialists, regulators, patient partners, and industry experts invited from all International Society of Nephrology regions. Discussions emphasized the importance of inclusive trial design, validation of patient-reported outcome measures, predictive enrichment strategies, and broader trial accessibility across resource settings. Key recommendations included enhancing diversity in trial populations, avoiding overreliance on isolated biomarkers, adopting novel study designs, strengthening public-private partnerships, and validating composite end points. A coordinated effort was deemed essential to implement these strategies in both research and practice, ensuring sustainable progress and reducing the global burden of kidney disease.

Keywords: chronic kidney disease; kidney; patient-reported outcomes.