University of Michigan Comprehensive Cancer Center, Ann Arbor, MI 48109, USA.
Sci Transl Med. 2013 Jul 31;5(196):196cm6. doi: 10.1126/scitranslmed.3005950.
Despite prodigious advances in tumor biology research, few tumor-biomarker tests have been adopted as standard clinical practice. This lack of reliable tests stems from a vicious cycle of undervaluation, resulting from inconsistent regulatory standards and reimbursement, as well as insufficient investment in research and development, scrutiny of biomarker publications by journals, and evidence of analytical validity and clinical utility. We offer recommendations designed to serve as a roadmap to break this vicious cycle and call for a national dialogue, as changes in regulation, reimbursement, investment, peer review, and guidelines development require the participation of all stakeholders.
尽管肿瘤生物学研究取得了巨大进展，但很少有肿瘤生物标志物检测被采纳为标准临床实践。这种缺乏可靠检测的情况源于一个恶性循环，即由于监管标准和报销不一致，以及对研发的投资不足，对生物标志物出版物的审查，以及对分析有效性和临床实用性的证据，导致这些检测的价值被低估。我们提供的建议旨在作为打破这一恶性循环的路线图，并呼吁进行全国性对话，因为监管、报销、投资、同行评审和指南制定的变化需要所有利益相关者的参与。
