Lin Chia-Chi
Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.
Chin Clin Oncol. 2019 Jun;8(3):25. doi: 10.21037/cco.2019.06.03.
In this article, the challenges and strategies of phase 1 drug development for lung cancer are discussed. These include the use of precise dose determinations via statistical modelling, the improved selection of patients based on genetic or molecular biomarkers, relevant pharmacokinetic and pharmacodynamic analyses, and the early evaluation of efficacy. The application of molecular tumor profiling for individualizing therapy is increasingly seen in phase I trials. Finally, the implication of a shift towards multi-institutional trials and centralized study management are discussed.
本文讨论了肺癌一期药物研发的挑战与策略。这些包括通过统计建模进行精确剂量测定、基于基因或分子生物标志物改进患者选择、相关的药代动力学和药效学分析以及疗效的早期评估。分子肿瘤图谱在个体化治疗中的应用在一期试验中越来越常见。最后，讨论了向多机构试验和集中式研究管理转变的影响。
