欧洲药品管理局(EMA)发布的《Guideline on the clinical evaluation of anticancer medicinal products v6》”中提及,若PFS被选为临床试验的主要终点,则OS应作为次要终点[4]。截至目前,奥拉帕利仍是唯一在卵巢癌一线维持治疗能兼顾PFS和OS...
with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol. 2016 May;17(5):577-89.[3] Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. ...
[5] Liang, F. Unstable Estimation of Investigator-Assessed Median Progression-Free Survival in the Updated Report of ALEX Trial. Journal of Thoracic Oncology. 2019; 14(9): e195-e196. [6] Amit O, et al. Blinded indepe...
3.Tang C, et al. Addition of Metastasis-Directed Therapy to Intermittent Hormone Therapy for Oligometastatic Prostate Cancer: The EXTEND Phase 2 Randomized Clinical Trial. JAMA Oncol. 2023 Jun 1;9(6):825-834. doi: 10.1001/jamaoncol.2023.0161. PMID: 37022702; PMCID: PMC10080407. 4.Addition of...
[5] Chaurasiya S, Yang A, Zhang Z, et al. A comprehensive preclinical study supporting clinical trial of oncolytic chimeric poxvirus CF33-hNIS-anti-PD-L1 to treat breast cancer. Mol Ther Methods Clin Dev 2022; 24: 102–116. [6] Mosele F, Deluche E, Lusque A, et al. Trastuzumab ...
RCT:随机对照试验(randomized controlled trials);SAT:单臂试验(single arm trial);BICR:盲态独立中心评估(Blinded Independent Central Review) 晚期NSCLC 新药注册临床试验的设计及终点考虑 ▍以肿瘤生物标志物富集人群的临床试验 1. 生物标志物: 生物标志物选择:需明确具体的生物标志物命名。
Forum on Neuroscience and Nervous System Disorders; Forum on Drug Discovery, Development, and Translation, Shore C, Hinners J, Khandekar E, Wizemann T, eds. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington (DC): National Academies ...
[3] Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial. Eur J Cancer. 2019 May;112:57-65. [4] Nivolumab versus Docetaxel in Advanced Non-squamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627...
参考文献: https://www.onclive.com/view/pfs-deserves-more-than-surrogate-status-as-a-clinical-trial-end-point
RCT:随机对照试验(randomized controlled trials);SAT:单臂试验(single arm trial);BICR:盲态独立中心评估(Blinded Independent Central Review) 晚期NSCLC 新药注册临床试验的设计及终点考虑 ▍以肿瘤生物标志物富集人群的临床试验 1. 生物标志物:...