A call for better reporting of trials using surrogate primary endpoints.
A call for better reporting of trials using surrogate primary endpoints.
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DOI：
10.1002/trc2.12340
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发表时间：
2022
影响因子：
4.8
通讯作者：
Taylor, Rod S
中科院分区：
文献类型：
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作者：
Manyara, Anthony Muchai;Ciani, Oriana;Taylor, Rod S
Cummings等人。最近审查了当前的随机对照试验(RCT)和正在开发的治疗阿尔茨海默病(AD)的药物。1这项综述的关键发现之一是增加了生物标志物的使用。1使用的一些生物标志物，如淀粉样蛋白减少，被视为替代终点；1，2即替代和预测患者相关结果3，如死亡或疾病进展。进行试验以支持开发慢性脑部疾病的治疗方法的成本非常高(在过去25年中，AD的费用为425亿美元)，因此必须采取措施降低试验成本。4此外，这种治疗方法的开发是复杂和困难的，因为它依赖于在高度进步的情况下证明健康益处。2因此，替代终点可能会提高试验效率，并允许更快地批准治疗。
Cummings et al. have recently reviewed current randomized controlled trials (RCTs) and drugs under development for Alzheimer’s disease (AD) treatment. 1 One of the key findings of this review was increased use of biomarkers as outcomes. 1 Some of the biomarkers used, such as reduction in amyloid, are regarded as surrogate endpoints; 1, 2 that is, substitutes and predictors of patient relevant outcomes 3 such as death or disease progression. The cost of conducting trials to support development of treatments of chronic brain conditions is extremely high (US $42.5 billion in the past 25 years for AD) necessitating measures to lower trial cost. 4 Additionally, development of such treatments is complex and difficult given it is dependent on demonstration of a health benefit on a highly progressive condition. 2 Therefore, surrogate endpoints may improve trial efficiency and allow faster approval of treatments.