A Strategic Roadmap to Support Communication on and Acceptance of Surrogate Endpoints: The REnal Surrogacy accEpTance in Chronic Kidney Disease (RESET CKD) Collaboration.

ABSTRACT:

Introduction

Developing effective treatments in chronic, progressive diseases like chronic kidney disease (CKD) is challenging because patients may only experience relevant outcomes such as kidney failure after long periods of disease progression. Surrogate endpoints provide a valuable alternative to definitive final patient-relevant outcomes, which may accelerate clinical development processes. However, optimal utilization of surrogate endpoints for reimbursement decisions requires alignment across multiple stakeholders, including health technology assessment (HTA) bodies and reimbursement agencies, who are generally more cautious than regulatory bodies in their acceptance of surrogate endpoint evidence. The aim of this paper is to propose a strategic roadmap to facilitate cross-s

SUBMITTER: Garcia Sanchez JJ 

PROVIDER: S-EPMC12579683 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature