New Enterprise Associates, Menlo Park, CA 94025, USA.
J Transl Med. 2012 Jul 2;10:138. doi: 10.1186/1479-5876-10-138.
This manuscript summarizes current thinking on the value and promise of evolving circulating tumor cell (CTC) technologies for cancer patient diagnosis, prognosis, and response to therapy, as well as accelerating oncologic drug development. Moving forward requires the application of the classic steps in biomarker development-analytical and clinical validation and clinical qualification for specific contexts of use. To that end, this review describes methods for interactive comparisons of proprietary new technologies, clinical trial designs, a clinical validation qualification strategy, and an approach for effectively carrying out this work through a public-private partnership that includes test developers, drug developers, clinical trialists, the US Food & Drug Administration (FDA) and the US National Cancer Institute (NCI).
这篇手稿总结了目前对于循环肿瘤细胞（CTC）技术在癌症患者诊断、预后和治疗反应中的价值和前景的思考，以及该技术在加速肿瘤药物开发方面的作用。为了实现这一目标，需要应用生物标志物开发的经典步骤——分析和临床验证，以及针对特定使用情况的临床资格认证。为此，本文描述了用于交互式比较专利新技术、临床试验设计、临床验证资格策略的方法，以及通过包括测试开发者、药物开发者、临床试验人员、美国食品和药物管理局（FDA）和美国国家癌症研究所（NCI）在内的公私合作伙伴关系来有效地开展这项工作的方法。
