Response: Re: Hypertension as a Biomarker of Efficacy in Patients With Metastatic Renal Cell Carcinoma Treated With Sunitinib
Response: Re: Hypertension as a Biomarker of Efficacy in Patients With Metastatic Renal Cell Carcinoma Treated With Sunitinib
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DOI：
10.1093/jnci/djr329
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发表时间：
2011-10
期刊：
影响因子：
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通讯作者：
B. Rini;D. Cohen;D. Lu;I. Chen;S. Hariharan;M. Gore;R. Figlin;M. Baum;R. Motzer
中科院分区：
文献类型：
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作者：
B. Rini;D. Cohen;D. Lu;I. Chen;S. Hariharan;M. Gore;R. Figlin;M. Baum;R. Motzer
在该杂志的前几期中，两篇评论(1，2)提出了癌症生物标记物研究的评估和临床翻译方案，包括根据设计特征(1，2)为个别研究分配证据权重。我们支持这些努力，但我们担心这些建议过分强调嵌套在临床试验中的研究，并惩罚没有有效基础的高质量前瞻性观察研究的证据。正如Simon等人(2)指出的那样，评估肿瘤标记物相关性的理想设计是将生物标记物知识纳入实验研究的随机方案。然而，他们和其他人(2，3)描述了为什么这样的试验可能不切实际的几个原因。这些不切实际的事实给我们留下了一个现实，在这个现实中，生物标记物研究的临床翻译必须依赖于非随机研究的证据。为了改进推理过程，Simon等人(2)划定了区分不同类型流行病学研究贡献的证据质量的界限[参考文献(2)中的表1]。我们不同意他们在嵌套在临床试验中的研究之间的区别，在临床试验中，生物标记物没有被纳入随机方案(他们的B类)和前瞻性观察研究(他们的C类)。因为这两种设计都没有赋予推理优势
In previous issues of the Journal, two commentaries (1, 2) proposed schemes for the evaluation and clinical translation of cancer biomarker research, including assigning evidence weights to individual studies based on design features (1, 2). We support these efforts, but we are concerned that the recommendations place undue emphasis on studies nested in clinical trials and penalize evidence from high-quality prospective observational studies without a valid basis.As Simon et al.(2) noted, the ideal design for evaluating tumor marker associations is to incorporate biomarker knowledge into the randomization scheme of an experimental study. However, they and others (2, 3) have delineated several reasons why such trials may be impractical. These impracticalities leave us with a reality in which clinical translation of biomarker research must rely on evidence from nonrandomized studies. To improve the inferential process, Simon et al.(2) drew boundaries that distinguish the quality of evidence contributed by different types of epidemiological study [Table 1 in reference (2)]. We disagree with their distinction between studies nested in clinical trials in which the biomarker was not incorporated into the randomization scheme (their category B) and prospective observational studies (their category C). Because neither design confers the inferential advantage of