Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association

Author:

Gruber Susan12,Chakravarty Aloka3,Heckbert Susan R.45,Levenson Mark3,Martin David6,Nelson Jennifer C.7,Psaty Bruce M.85,Pinheiro Simone9,Reich Christian G.10,Toh Sengwee2,Walker Alexander M.11

Affiliation:

1. Reagan-Udall Foundation for the FDA; Innovation in Medical Evidence Development and Surveillance; Washington DC USA

2. Department of Population Medicine; Harvard Medical School and Harvard Pilgrim Health Care Institute; Boston MA USA

3. Office of Biostatistics, Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD USA

4. Cardiovascular Health Research Unit, Department of Epidemiology; University of Washington; Seattle WA USA

5. Group Health Research Institute; Group Health Cooperative; Seattle WA USA

6. Office of the Center Director, Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD USA

7. Biostatistics Unit, Group Health Research Institute, Department of Biostatistics; University of Washington; Seattle WA USA

8. Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services; University of Washington; Seattle WA USA

9. Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD USA

10. RWE Systems; IMS Health; Burlington MA USA

11. WHISCON; Newton MA USA

Funder

Reagan-Udall Foundation for the FDA

US Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

同舟云学术

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