Transparent and complete reporting of surrogate endpoints in trials: the SPIRIT-Surrogate and CONSORT-Surrogate extensions

The Lancet

11 July 2024 - Randomised trials are resource-intensive studies that provide robust evidence for evaluating the effectiveness of interventions. 

Two reporting guidelines have improved the reporting of trials over the years: SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) for trial protocols and CONSORT (Consolidated Standards of Reporting Trials) for trial reports.  However, these guidelines are not always sufficient for adequate reporting of all types of trials, such as those using surrogate endpoints as primary outcomes.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation