Samuels Joshua
Pediatric Nephrology and Hypertension, University of Texas McGovern Medical School at Houston, Houston, TX.
Adv Chronic Kidney Dis. 2016 Nov;23(6):363-366. doi: 10.1053/j.ackd.2016.11.008.
Clinical trials are large and expensive and could require exceedingly long-term follow-up for subjects to reach clinically meaningful end points. To combat these methodologic issues, researchers sometimes use biomarkers as surrogate end points. A biomarker is an objectively measured characteristic that is indicative of some underlying phenomenon or process, while a surrogate is a biomarker that "takes the place" of a clinically meaningful outcome, usually earlier in the disease process. This paper reviews the history, strengths, and weaknesses of surrogate outcome use in clinical research and then discusses potential surrogate outcomes in nephrology research.
临床试验规模大、成本高，可能需要对受试者进行极其长期的随访，才能达到具有临床意义的终点。为应对这些方法学问题，研究人员有时会使用生物标志物作为替代终点。生物标志物是一种客观测量的特征，可指示某些潜在现象或过程，而替代指标是一种生物标志物，它“替代”了具有临床意义的结局，通常在疾病过程中出现得更早。本文回顾了临床研究中使用替代结局的历史、优点和缺点，然后讨论了肾脏病学研究中的潜在替代结局。
