Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration's Approval of Oncology Drugs
Author:
Publisher
Elsevier BV
Subject
General Medicine
Reference75 articles.
1. Oncology drug development: United States Food and Drug Administration perspective;Hirschfeld;Crit Rev Oncol Hematol,2002
2. End points and United States Food and Drug Administration approval of oncology drugs;Johnson;J Clin Oncol,2003
3. Endpoints for assessing drug activity in clinical trials;Pazdur;Oncologist,2008
4. Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007;Sridhara;J Natl Cancer Inst,2010
5. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer;Miller;N Engl J Med,2007
Cited by 94 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. Understanding the Challenges Associated with Approval of Anticancer Products to Facilitate the Regulatory Approvals: A Cross-sectional Study;Current Cancer Therapy Reviews;2024-11
2. Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration;BMJ;2024-07-09
3. Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration;BMJ;2024-07-09
4. Clarifying Causal Effects of Interest and Underlying Assumptions in Randomized and Nonrandomized Clinical Trials in Oncology Using Directed Acyclic Graphs and Single-World Intervention Graphs;JCO Clinical Cancer Informatics;2024-06
5. An empirical analysis of overall survival in drug approvals by the US FDA (2006–2023);Cancer Medicine;2024-04
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