Use of surrogate endpoints in health technology assessment and reimbursement of treatments for the management of chronic kidney disease.

ABSTRACT: The judicious use of surrogate endpoints as substitutes for patient relevant target outcomes can substantially reduce the size and duration of clinical trials, thereby driving down research and development costs and driving faster patient access to innovative therapies. Whilst increasingly used by regulators over the last two decades, health technology assessment (HTA) agencies and payers have been more sceptical in acceptance of surrogates in their reimbursement decisions. Central to acceptance is scientific validation and demonstration of the association in the treatment effect on the surrogate endpoint and target outcome. This review summarises the validity and utility of glomerular filtration rate (GFR) slope as a 'first in class' surrogate with robust evidence of a strong treatment ef

SUBMITTER: Taylor RS 

PROVIDER: S-EPMC12418889 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature