用于将预测性生物标志物最佳地整合到肿瘤学临床开发项目中的新的循证适应性临床试验方法。
New evidence-based adaptive clinical trial methods for optimally integrating predictive biomarkers into oncology clinical development programs.
作者信息
Beckman Robert A, Chen Cong
机构信息
Daiichi Sankyo Pharmaceutical Development, Edison, NJ 08837, USA.
出版信息
Chin J Cancer. 2013 May;32(5):233-41. doi: 10.5732/cjc.012.10248. Epub 2013 Mar 15.
Abstract
Predictive biomarkers are important to the future of oncology; they can be used to identify patient populations who will benefit from therapy, increase the value of cancer medicines, and decrease the size and cost of clinical trials while increasing their chance of success. But predictive biomarkers do not always work. When unsuccessful, they add cost, complexity, and time to drug development. This perspective describes phases 2 and 3 development methods that efficiently and adaptively check the ability of a biomarker to predict clinical outcomes. In the end, the biomarker is emphasized to the extent that it can actually predict.
摘要
预测性生物标志物对肿瘤学的未来至关重要；它们可用于识别将从治疗中获益的患者群体，提高癌症药物的价值，降低临床试验的规模和成本，同时增加试验成功的机会。但预测性生物标志物并非总能发挥作用。若未成功，它们会增加药物开发的成本、复杂性和时间。本文阐述了2期和3期开发方法，这些方法能有效且适应性地检验生物标志物预测临床结果的能力。最后，生物标志物的重要性在于其实际预测能力。
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