根據(jù)在線發(fā)表于1月14日《美國(guó)國(guó)家癌癥研究院期刊》上的評(píng)論,，一種隨機(jī)復(fù)合生物標(biāo)志物計(jì)劃，也就是用生物標(biāo)志物指導(dǎo)分析但不是指導(dǎo)治療安排的方法,，提供了對(duì)指導(dǎo)治療的潛在生物標(biāo)志物使用的一種嚴(yán)格評(píng)價(jià)。
在評(píng)論中,，馬里蘭州貝塞斯達(dá)美國(guó)國(guó)家癌癥研究院生物研究部的Boris Freidlin博士,，與同事們討論了一般使用的隨機(jī)臨床試驗(yàn)設(shè)計(jì)的優(yōu)點(diǎn)與缺點(diǎn)，其中包括生物標(biāo)志物分層,、富集與生物標(biāo)志物策略設(shè)計(jì),。
根據(jù)作者所說(shuō),，臨床生物標(biāo)志物測(cè)試將在癌癥病人個(gè)性化醫(yī)療完成中發(fā)揮重要作用。
以三種設(shè)計(jì)的綜合評(píng)論為根據(jù),，研究人員總結(jié)到,，當(dāng)論及切實(shí)可行時(shí)，生物標(biāo)志物分層設(shè)計(jì)通常最好,，因?yàn)樗麄冿@示出生物標(biāo)志物與治療效果間關(guān)系的完整信息,。在這個(gè)設(shè)計(jì)中，不管生物標(biāo)志物的狀態(tài),，患者被隨機(jī)分組,，但是分析圍繞生物標(biāo)志物與治療效果間關(guān)系展開(kāi)。
作者寫(xiě)道："生物標(biāo)志物分層設(shè)計(jì)使隨機(jī)化優(yōu)勢(shì)最大化,，它提供不同生物標(biāo)志物界定的小分組中益處與風(fēng)險(xiǎn)比率的無(wú)偏差評(píng)估,，也提供整個(gè)隨機(jī)設(shè)計(jì)樣本的。"（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.
