解读树叶——如何丰富糖尿病肾病的临床试验
Reading the tree leaves-how to enrich clinical trials of diabetic kidney disease.
作者信息
Looker Helen C, Nelson Robert G
机构信息
Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA.
Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA.
出版信息
Kidney Int. 2017 Jul;92(1):23-25. doi: 10.1016/j.kint.2017.03.042.
Abstract
Most participants selected for clinical trials of renoprotective drugs do not reach approved endpoints; thus, large trials or prolonged follow-up are needed to achieve adequate statistical power. Yamanouchi et al. used a classification and regression trees analysis to enrich enrollment criterion for patients at the highest risk of reaching these outcomes. Their findings suggest a greater role for newly identified biomarkers of diabetic kidney disease in the selection of participants for clinical trials.
摘要
大多数入选肾脏保护药物临床试验的参与者未达到批准的终点；因此，需要进行大型试验或延长随访时间以获得足够的统计效力。山之内等人使用分类回归树分析来丰富对最有可能出现这些结果的患者的纳入标准。他们的研究结果表明，新发现的糖尿病肾病生物标志物在选择临床试验参与者方面具有更大作用。
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