根据在线发表于1月14日《美国国家癌症研究院期刊》上的评论，一种随机复合生物标志物计划，也就是用生物标志物指导分析但不是指导治疗安排的方法，提供了对指导治疗的潜在生物标志物使用的一种严格评价。
在评论中，马里兰州贝塞斯达美国国家癌症研究院生物研究部的Boris Freidlin博士，与同事们讨论了一般使用的随机临床试验设计的优点与缺点，其中包括生物标志物分层、富集与生物标志物策略设计。
根据作者所说，临床生物标志物测试将在癌症病人个性化医疗完成中发挥重要作用。
以三种设计的综合评论为根据，研究人员总结到，当论及切实可行时，生物标志物分层设计通常最好，因为他们显示出生物标志物与治疗效果间关系的完整信息。在这个设计中，不管生物标志物的状态，患者被随机分组，但是分析围绕生物标志物与治疗效果间关系展开。
作者写道："生物标志物分层设计使随机化优势最大化，它提供不同生物标志物界定的小分组中益处与风险比率的无偏差评估，也提供整个随机设计样本的。"（生物谷bioon.com)
doi:10.1093/jnci/djp477
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PMID:
Randomized Clinical Trials With Biomarkers: Design Issues
Boris Freidlin, Lisa M. McShane and Edward L. Korn
Clinical biomarker tests that aid in making treatment decisions will play an important role in achieving personalized medicine for cancer patients. Definitive evaluation of the clinical utility of these biomarkers requires conducting large randomized clinical trials (RCTs). Efficient RCT design is therefore crucial for timely introduction of these medical advances into clinical practice, and a variety of designs have been proposed for this purpose. To guide design and interpretation of RCTs evaluating biomarkers, we present an in-depth comparison of advantages and disadvantages of the commonly used designs. Key aspects of the discussion include efficiency comparisons and special interim monitoring issues that arise because of the complexity of these RCTs. Important ongoing and completed trials are used as examples. We conclude that, in most settings, randomized biomarker-stratified designs (ie, designs that use the biomarker to guide analysis but not treatment assignment) should be used to obtain a rigorous assessment of biomarker clinical utility.
