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

Disparities between regulatory and reimbursement processes and decisions underscore the need for a structured approach to enhancing transparency, consistency, and timeliness in the use of surrogate endpoint evidence in healthcare decision-making. The roadmap developed through the RESET CKD Collaboration addresses this need and is already demonstrating practical value in its implementation. Although initially focused on CKD, the framework is designed to be transferable to other therapeutic areas. Key challenges remain, including the integration of surrogate endpoints into adaptive pricing models and performance-based agreements.

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Publication Details

Journal
Advances in Therapy
Published
2025-09-23
DOI
https://doi.org/10.1007/s12325-025-03370-w
Primary Topic
Reproductive Health and Technologies
Type
article
Field-Weighted Citation Impact
0.00
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article

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

You‐Seon Nam, Loreto Gesualdo, Oriana Ciani, Marta Trapero‐Bertran et al.
Advances in Therapy
Reproductive Health and Technologies
article

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

You‐Seon Nam, Loreto Gesualdo, Oriana Ciani, Marta Trapero‐Bertran, B. Detournay, Dustin J. Little, Hiddo J.L. Heerspink, Juan José García Sánchez, R. S. Taylor, Marvin Sinsakul, Lesley A. Inker, Smeeta Sinha, Christoph Wanner
article en

Abstract

Disparities between regulatory and reimbursement processes and decisions underscore the need for a structured approach to enhancing transparency, consistency, and timeliness in the use of surrogate endpoint evidence in healthcare decision-making. The roadmap developed through the RESET CKD Collaboration addresses this need and is already demonstrating practical value in its implementation. Although initially focused on CKD, the framework is designed to be transferable to other therapeutic areas. Key challenges remain, including the integration of surrogate endpoints into adaptive pricing models and performance-based agreements.

Advances in TherapyVol. 42(11)
Tufts Medical Center (US), University Medical Center Groningen (NL), Universitat de Lleida (ES), Manchester Academic Health Science Centre (GB), University of Manchester (GB), Cemka-Eval (France) (FR), AstraZeneca (France) (FR), Salford Royal Hospital (GB), MRC/CSO Social and Public Health Sciences Unit (GB), AstraZeneca (Netherlands) (NL), Universitätsklinikum Würzburg (DE), AstraZeneca (Poland) (PL), AstraZeneca (Finland) (FI), AstraZeneca (Spain) (ES), AstraZeneca (United States) (US), University of Bari Aldo Moro (IT), Bocconi University (IT)
Openalex Percentile: Top 66%
Reproductive Health and Technologies
DOIOpen Access PDFOpenAlex
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