A Regulatory Perspective on Essential Considerations in Design and Analysis of Subgroups When Correctly Classified
Author:
Affiliation:
1. a Office of Biostatistics, OTS/CDER , Food and Drug Administration , Silver Spring , Maryland , USA
2. b Division of Biometrics I, OB/OTS/CDER , Food and Drug Administration , Silver Spring , Maryland , USA
Publisher
Informa UK Limited
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
https://www.tandfonline.com/doi/pdf/10.1080/10543406.2013.856022
Reference41 articles.
1. Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology
2. Brilinta label. ( 2013 ). Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/ 2013/022433s006lbl.pdf
3. Subgroup analyses in randomized trials: risks of subgroup-specific analyses;
4. Cold comfort
5. ISSUES RELATED TO SUBGROUP ANALYSIS IN CLINICAL TRIALS
Cited by 24 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. Biomarker-Driven Oncology Trial Design and Subgroup Characterization: Challenges and Potential Solutions;JCO Precision Oncology;2024-07
2. Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection;Therapeutic Innovation & Regulatory Science;2021-11-28
3. Incorporating covariates information in adaptive clinical trials for precision medicine;Pharmaceutical Statistics;2021-08-09
4. REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person ‘Managing Fatigue’ interventions on the impact of fatigue among persons with multiple sclerosis;BMJ Open;2020-08
5. Data-Driven and Confirmatory Subgroup Analysis in Clinical Trials;Emerging Topics in Statistics and Biostatistics;2020
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