Surrogate endpoints in trials: a call for better reporting

被引：3

作者：

Ciani, Oriana ^{[1
]}

Manyara, Anthony M. ^{[2
]}

Chan, An-Wen ^{[3
,4
]}

Taylor, Rod S. ^{[2
,5
]}

机构：

[1] SDA Bocconi Sch Management, Milan, Italy

[2] Univ Glasgow, Inst Hlth & Wellbeing, MRC CSO Social & Publ Hlth Sci Unit, Berkeley Sq,99 Berkeley St, Glasgow G3 7HR, Lanark, Scotland

[3] Univ Toronto, Womens Coll Inst Res Inst, Toronto, ON, Canada

[4] Univ Toronto, Dept Med, Toronto, ON, Canada

[5] Univ Glasgow, Inst Hlth & Wellbeing, Robertson Ctr Biostat, Berkeley Sq,99 Berkeley St, Glasgow G3 7HR, Lanark, Scotland

来源：

TRIALS | 2022年 / 23卷 / 01期

基金：

英国医学研究理事会;

关键词：

Surrogate endpoints; Randomised trials;

D O I：

10.1186/s13063-022-06904-7

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Using a surrogate endpoint as a substitute for a patient-relevant final outcome enables randomised controlled trials (RCTs) to be conducted more efficiently. However, the use of surrogates remains controversial and there is currently no guideline for the reporting of RCTs using surrogate endpoints; therefore, we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the reporting of these trials. We would like to invite interested individuals (trial methodologists, journal editors, healthcare industry, regulators and payers, and patient/public representative groups), particularly those with experience in the use of surrogate endpoints in trials.

引用

页数：4

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