SDA Bocconi School of Management, Milan, Italy.
MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Trials. 2022 Dec 12;23(1):991. doi: 10.1186/s13063-022-06904-7.
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.
使用替代终点作为替代与患者相关的最终结局，可以使随机对照试验（RCT）更有效地进行。然而，替代终点的使用仍然存在争议，目前还没有关于使用替代终点的 RCT 报告的指南；因此，我们希望制定 SPIRIT（标准议定书项目：干预试验推荐）和 CONSORT（临床试验报告的统一标准）扩展，以改进这些试验的报告。我们想邀请感兴趣的个人（试验方法学家、期刊编辑、医疗保健行业、监管机构和支付方以及患者/公众代表团体），特别是那些在试验中使用替代终点方面有经验的人。
