Need for better reporting of trials with surrogate endpoints: SPIRIT|CONSORT-SURROGATE extensions

Evidence for the effectiveness of health interventions should ideally come from randomised trials that assess a participant relevant final outcome (PRFO), such as health status or survival.1 2 However, such trials often require large sample sizes, long follow-up times and are resource intensive and costly.2 Surrogate endpoints or ‘surrogates’ have been used to improve trial efficiency by acting as a proxy and predictor for PRFOs.3 Over the last two decades, drug licensing in the USA and Europe has allowed the use of biomarkers (an objectively measured molecular, histologic, radiographic or physiologic characteristic) as surrogates in the approval of new therapies, for example, systolic blood pressure and/glycosylated haemoglobin (HbA1c) for cardiovascular death, HIV viral load for development of AIDS and tumour response for overall survival.3 4 However, it is important to recognise the application of surrogates in the...

Source: Journal of Epidemiology and Community Health - August 10, 2022 Category: Epidemiology Authors: Ciani, O., Manyara, A., Taylor, R. S. Tags: Open access Commentaries Source Type: research