TY - JOUR T1 - Need for better reporting of trials with surrogate endpoints: SPIRIT|CONSORT-SURROGATE extensions JF - Journal of Epidemiology and Community Health JO - J Epidemiol Community Health DO - 10.1136/jech-2022-219294 SP - jech-2022-219294 AU - Oriana Ciani AU - Anthony Manyara AU - Rod S Taylor Y1 - 2022/06/23 UR - http://jech.bmj.com/content/early/2022/07/20/jech-2022-219294.abstract N2 - 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 wider setting of healthcare evaluation (including trials of public health, diagnostic, surgical, mental health, primary care, rehabilitation interventions) and the use of so-called intermediate outcomes (outcome on the causal path for PRFO that can be measured earlier … ER -