Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies
Author:
Affiliation:
1. Office of Hematology Oncology Products, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Silver Spring, Maryland, USA
2. Oncology Center of Excellence U.S. Food and Drug Administration, Silver Spring, Maryland, USA
Abstract
Publisher
Oxford University Press (OUP)
Subject
Cancer Research,Oncology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1634/theoncologist.2017-0152
Reference49 articles.
1. Expediting drug development—The FDA's new “breakthrough therapy” designation;Sherman;N Engl J Med,2013
2. Regulatory Watch: Impact of breakthrough therapy designation on cancer drug development;Shea;Nat Rev Drug Discov,2016
3. Endpoints for assessing drug activity in clinical trials;Pazdur;The Oncologist,2008
4. Acute lymphoblastic leukemia in children;Hunger;N Engl J Med,2015
5. Cis-diamminedichloroplatinum, vinblastine, and bleomycin combination chemotherapy in disseminated testicular cancer;Einhorn;Ann Intern Med,1977
Cited by 53 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
1. Efficacy and Safety of PD-1/PD-L1 Inhibitor as Single-Agent Immunotherapy in Endometrial Cancer: A Systematic Review and Meta-Analysis;Cancers;2023-08-09
2. E2EFP-MIL: End-to-end and high-generalizability weakly supervised deep convolutional network for lung cancer classification from whole slide image;Medical Image Analysis;2023-08
3. FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements;Clinical Cancer Research;2023-06-08
4. Reply to Di Nunno et al. concerning objective response rates targets for recurrent glioblastoma clinical trials: Toward surrogate endpoints for phase II trials in patients with recurrent glioblastoma;Neuro-Oncology;2023-05-11
5. Assessment of Surrogate End Point Trends in Clinical Trials to Approve Oncology Drugs From 2001 to 2020 in Japan;JAMA Network Open;2023-04-28
1.学者识别学者识别
2.学术分析学术分析
3.人才评估人才评估
"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370
www.globalauthorid.com
TOP
Copyright © 2019-2024 北京同舟云网络信息技术有限公司 京公网安备11010802033243号 京ICP备18003416号-3