Objectives: Surrogate endpoints, used to substitute for and predict final clinical outcomes, are increasingly being used to support submissions to health technology assessment agencies. The increase in use of surrogate endpoints has been accompanied by literature describing frameworks and statistical methods to ensure their robust validation. The aim of this review was to assess how surrogate endpoints have recently been used in oncology technology appraisals by the National Institute for Health and Care Excellence (NICE) in England and Wales. Methods: This paper identified technology appraisals in oncology published by NICE between February 2022 and May 2023. Data are extracted on methods for the use and validation of surrogate endpoints. Results: Of the 47 technology appraisals in oncology available for review, 18 (38 percent) utilised surrogate endpoints, with 37 separate surrogate endpoints being discussed. However, the evidence supporting the validity of the surrogate relationship varied significantly across putative surrogate relationships with 11 providing RCT evidence, 7 providing evidence from observational studies, 12 based on clinical opinion and 7 providing no evidence for the use of surrogate endpoints. Conclusions: This review supports the assertion that surrogate endpoints are frequently used in oncology technology appraisals in England and Wales. Despite increasing availability of statistical methods and guidance on appropriate validation of surrogate endpoints, this review highlights that use and validation of surrogate endpoints can vary between technology appraisals which can lead to uncertainty in decision-making.

翻译：目的：替代终点作为最终临床结局的替代与预测指标，正日益广泛地应用于卫生技术评估机构的申报材料中。随着替代终点使用频率的增加，相关文献提出了多种框架与统计方法以确保其验证的严谨性。本综述旨在评估英格兰与威尔士地区国家卫生与临床优化研究所在近期肿瘤学技术评估中对替代终点的应用情况。方法：本文识别了NICE在2022年2月至2023年5月期间发布的肿瘤学技术评估报告，并提取了关于替代终点使用与验证方法的相关数据。结果：在可供审查的47项肿瘤学技术评估中，18项（38%）使用了替代终点，共涉及37个独立的替代终点指标。然而，不同替代关系验证证据的质量存在显著差异：其中11项提供了随机对照试验证据，7项提供了观察性研究证据，12项基于临床专家意见，另有7项未提供任何支持使用替代终点的证据。结论：本综述证实了替代终点在英格兰与威尔士地区肿瘤学技术评估中的广泛应用。尽管当前已有日益增多的统计方法与指南可用于替代终点的规范验证，但本研究发现不同技术评估中对替代终点的使用与验证方式存在差异，这种不一致可能导致决策过程中的不确定性。