Single‐Arm Clinical Trials as Pivotal Evidence for Cancer Drug Approval: A Retrospective Cohort Study of Centralized European Marketing Authorizations Between 2010 and 2019
Author:
Affiliation:
1. Medical Research Center Oulu Oulu University Hospital University of Oulu Oulu Finland
2. Finnish Medicines Agency Helsinki Finland
3. Hannover Medical School Hannover Germany
4. Norwegian Medicines Agency Oslo Norway
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1965
Reference20 articles.
1. Seamless designs: current practice and considerations for early‐phase drug development in oncology;Hobbs B.P.;J. Natl. Cancer Inst.,2019
2. Seamless Oncology-Drug Development
3. European Medicines Agency (EMA).Guideline on the evaluation of anticancer medicinal products in man.. Accessed February 18 2020.
4. Personalized medicine in oncology: the future is now
5. Basket Trials and the Evolution of Clinical Trial Design in an Era of Genomic Medicine
Cited by 26 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. Using non-randomized trials to assess the clinical benefit of systemic anti-cancer treatments: Viable or not?;European Journal of Cancer;2024-09
2. Real-world evidence reported for clinical efficacy evaluation in European Public Assessment Reports of authorised targeted therapies for solid malignancies: a comprehensive review (2018-2022);ESMO Real World Data and Digital Oncology;2024-06
3. Justifying the source of external comparators in single-arm oncology health technology submissions: a review of NICE and PBAC assessments;Journal of Comparative Effectiveness Research;2024-02
4. Unanchored Population-Adjusted Indirect Comparison Methods for Time-to-Event Outcomes Using Inverse Odds Weighting, Regression Adjustment, and Doubly Robust Methods With Either Individual Patient or Aggregate Data;Value in Health;2023-12
5. Review time of oncology drugs and its underlying factors: an exploration in China;Frontiers in Pharmacology;2023-11-01
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