Consensus report of a joint NCI thoracic malignancies steering committee: FDA workshop on strategies for integrating biomarkers into clinical development of new therapies for lung cancer leading to the inception of "master protocols" in lung cancer.
Consensus report of a joint NCI thoracic malignancies steering committee: FDA workshop on strategies for integrating biomarkers into clinical development of new therapies for lung cancer leading to the inception of "master protocols" in lung cancer.
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DOI：
10.1097/jto.0000000000000314
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发表时间：
2014-10
期刊：
影响因子：
--
通讯作者：
Hirsch FR
中科院分区：
文献类型：
--
作者：
Malik SM;Pazdur R;Abrams JS;Socinski MA;Sause WT;Harpole DH Jr;Welch JJ;Korn EL;Ullmann CD;Hirsch FR
2012年2月2日，美国国家癌症研究所（NCI）与NCI胸部恶性肿瘤指导委员会和美国食品和药物管理局共同主办了为期两天的研讨会，汇集了领先的院士、临床医生、行业和政府代表，以确定肺癌新型靶向治疗临床开发中的挑战和潜在解决方案。从科学和监管的角度来看，成功的衡量标准正在迅速发展，本次研讨会的目标是就一项高优先级生物标志物驱动的临床试验达成初步共识，该试验旨在快速评估靶向药物在分子定义的肺癌亚群中的活性，并促进数据的生成，从而导致这些新疗法的批准。此外，会议的重点是查明进行这种试验的障碍和制定克服这些障碍的战略。NCI最近推出的“肺主协议”是本次研讨会的直接成果。
On February 2, 2012, the National Cancer Institute (NCI) sponsored a 2-day workshop with the NCI Thoracic Malignancies Steering Committee and the Food and Drug Administration to bring together leading academicians, clinicians, industry and government representatives to identify challenges and potential solutions in the clinical development of novel targeted therapies for lung cancer. Measures of success are rapidly evolving from a scientific and regulatory perspective and the objectives of this workshop were to achieve initial consensus on a high priority biomarker-driven clinical trial designed to rapidly assess the activity of targeted agents in molecularly defined lung cancer subsets and to facilitate generation of data leading to approval of these new therapies. Additionally, the meeting focused on identification of the barriers to conduct such a trial and the development of strategies to overcome those barriers. The “Lung Master Protocols” recently launched by NCI were the direct outcome of this workshop.