The Use of Genomics in Clinical Trial Design
The Use of Genomics in Clinical Trial Design
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DOI：
10.1158/1078-0432.ccr-07-4531
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发表时间：
2008-10-01
影响因子：
11.5
通讯作者：
Simon, Richard
中科院分区：
文献类型：
--
作者：
Simon, Richard
许多癌症治疗只能使接受治疗的少数患者受益。这给病人和卫生保健系统带来了巨大的负担。随着越来越多地使用分子靶向药物，这个问题将变得更加严重，除非对药物开发过程进行修改，以包括伴随诊断的共同开发，否则这些药物的益处可能更具选择性。全基因组生物技术和基因组测序成本的降低，使得肿瘤治疗领域的预测医学时代越来越有可能实现。这些挑战数量众多，但主要不是技术方面的。它们涉及组织公共资助的对解除管制途径的诊断，采用药物开发的新范式，以及制定激励措施，促使工业界承担共同开发药物和伴随诊断的复杂性和费用。本文回顾了一些III期临床试验的设计，这些设计可能有助于向更具预测性的肿瘤学方向发展。
Many cancer treatments benefit only a minority of patients who receive them. This results in an enormous burden on patients and on the health care system. The problem will become even greater with the increasing use of molecularly targeted agents whose benefits are likely to be more selective unless the drug development process is modified to include codevelopment of companion diagnostics. Whole genome biotechnology and decreasing costs of genome sequencing make it increasingly possible to achieve an era of predictive medicine in oncology therapeutics. The challenges are numerous and substantial but are not primarily technological. They involve organizing publicly funded diagnostics of deregulated pathways, adopting new paradigms for drug development, and developing incentives for industry to incur the complexity and expense of codevelopment of drugs and companion diagnostics. This article reviews some designs for phase III clinical trials that may facilitate movement to a more predictive oncology.