Simon Richard
Biometric Research Branch, National Cancer Institute, 9000 Rockville Pike, Bethesda, MD 20892, USA.
Clin Cancer Res. 2008 Oct 1;14(19):5984-93. doi: 10.1158/1078-0432.CCR-07-4531.
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 co-development 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 co-development of drugs and companion diagnostics. This article reviews some designs for phase III clinical trials that may facilitate movement to a more predictive oncology.
许多癌症治疗方法仅使少数接受治疗的患者受益。这给患者和医疗保健系统带来了巨大负担。随着分子靶向药物的使用增加，这个问题将变得更加严重，除非改进药物开发过程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在肿瘤治疗中实现预测医学时代的可能性越来越大。挑战众多且艰巨，但主要不是技术方面的。它们涉及组织对失调通路的公共资助诊断、采用新的药物开发范式，以及为行业提供激励措施，使其承担药物和伴随诊断共同开发的复杂性和费用。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迈进。
