National Cancer Institute, Raritan, New Jersey, USA.
Clin Cancer Res. 2010 Jul 1;16(13):3299-318. doi: 10.1158/1078-0432.CCR-10-0880. Epub 2010 May 25.
Recent discoveries in cancer biology have greatly increased our understanding of cancer at the molecular and cellular level, but translating this knowledge into safe and effective therapies for cancer patients has proved to be challenging. There is a growing imperative to modernize the drug development process by incorporating new techniques that can predict the safety and effectiveness of new drugs faster, with more certainty, and at lower cost. Biomarkers are central to accelerating the identification and adoption of new therapies, but currently, many barriers impede their use in drug development and clinical practice. In 2007, the AACR-FDA-NCI Cancer Biomarkers Collaborative stepped into the national effort to bring together disparate stakeholders to clearly delineate these barriers, to develop recommendations for integrating biomarkers into the cancer drug development enterprise, and to set in motion the necessary action plans and collaborations to see the promise of biomarkers come to fruition, efficiently delivering quality cancer care to patients.
近年来，癌症生物学的新发现极大地提高了我们在分子和细胞水平上对癌症的认识，但将这些知识转化为癌症患者安全有效的治疗方法一直具有挑战性。通过采用新的技术，以更快、更确定和更低的成本来预测新药的安全性和有效性，从而使药物开发过程现代化的需求日益迫切。生物标志物是加速鉴定和采用新疗法的核心，但目前，许多障碍阻碍了它们在药物开发和临床实践中的应用。2007 年，美国癌症研究协会-美国食品和药物管理局-美国国立癌症研究所癌症生物标志物合作组织参与了国家努力，将不同的利益相关者聚集在一起，明确界定这些障碍，制定将生物标志物纳入癌症药物开发企业的建议，并启动必要的行动计划和合作，以实现生物标志物的承诺，为患者提供高质量的癌症护理。
