万络事件后的临床试验：需要统计学上极为显著的获益证据以确保新药的安全性。 - Suppr

Suppr

超能文献

Clinical trials in the wake of Vioxx: requiring statistically extreme evidence of benefit to ensure the safety of new drugs.

作者信息

Roth-Cline Michelle D

机构信息

Department of Statistics, University of Wisconsin, Madison, WI 53792, USA.

出版信息

Circulation. 2006 May 9;113(18):2253-9. doi: 10.1161/CIRCULATIONAHA.105.604512.

DOI:10.1161/CIRCULATIONAHA.105.604512

PMID:16684875

Abstract

摘要

相似文献

Clinical trials in the wake of Vioxx: requiring statistically extreme evidence of benefit to ensure the safety of new drugs.

Circulation. 2006 May 9;113(18):2253-9. doi: 10.1161/CIRCULATIONAHA.105.604512.

Evaluating drug effects in the post-Vioxx world: there must be a better way.

Circulation. 2006 May 9;113(18):2173-6. doi: 10.1161/CIRCULATIONAHA.106.625749.

The Vioxx debacle.

IEEE Eng Med Biol Mag. 2005 Mar-Apr;24(2):106-9. doi: 10.1109/memb.2005.1411356.

The Vioxx fallout.

Minn Med. 2005 Mar;88(3):26-30.

The Vioxx debacle revisited.

Am J Med. 2005 Sep;118(9):1058. doi: 10.1016/j.amjmed.2005.06.045.

How to avoid another 'Vioxx'.

Nat Rev Drug Discov. 2005 Jan;4(1):5-7. doi: 10.1038/nrd1629.

[Overestimated].

Med Klin (Munich). 2006 Aug 15;101(8):676-7; author reply 678-9.

The vexations of Vioxx.

CMAJ. 2006 Feb 14;174(4):444-5. doi: 10.1503/cmaj.060041.

Balancing the cyclooxygenase portfolio.

CMAJ. 2006 May 23;174(11):1581-2. doi: 10.1503/cmaj.060471.

The sad story of Vioxx, and what we should learn from it.

Cleve Clin J Med. 2004 Dec;71(12):933-4, 936, 938-9. doi: 10.3949/ccjm.71.12.933.

引用本文的文献

Modelling of mouse experimental colitis by global property screens: a holistic approach to assess drug effects in inflammatory bowel disease.

PLoS One. 2012;7(1):e30005. doi: 10.1371/journal.pone.0030005. Epub 2012 Jan 18.

Should benefit-risk assessment have its own drug "label"?

Drug Healthc Patient Saf. 2011;3:37-41. doi: 10.2147/DHPS.S21927. Epub 2011 Aug 3.

Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy.

Drug Saf. 2008;31(7):609-16. doi: 10.2165/00002018-200831070-00006.

Captive subjects: pharmaceutical testing and prisoners.

J Med Toxicol. 2007 Mar;3(1):37-9. doi: 10.1007/BF03161037.

文献AI研究员

20分钟写一篇综述，助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型，支持多种主流文档格式。

立即体验

相似文献

Clinical trials in the wake of Vioxx: requiring statistically extreme evidence of benefit to ensure the safety of new drugs.

Circulation. 2006 May 9;113(18):2253-9. doi: 10.1161/CIRCULATIONAHA.105.604512.

Evaluating drug effects in the post-Vioxx world: there must be a better way.

Circulation. 2006 May 9;113(18):2173-6. doi: 10.1161/CIRCULATIONAHA.106.625749.

The Vioxx debacle.

IEEE Eng Med Biol Mag. 2005 Mar-Apr;24(2):106-9. doi: 10.1109/memb.2005.1411356.

The Vioxx fallout.

Minn Med. 2005 Mar;88(3):26-30.

The Vioxx debacle revisited.

Am J Med. 2005 Sep;118(9):1058. doi: 10.1016/j.amjmed.2005.06.045.

How to avoid another 'Vioxx'.

Nat Rev Drug Discov. 2005 Jan;4(1):5-7. doi: 10.1038/nrd1629.

[Overestimated].

Med Klin (Munich). 2006 Aug 15;101(8):676-7; author reply 678-9.

The vexations of Vioxx.

CMAJ. 2006 Feb 14;174(4):444-5. doi: 10.1503/cmaj.060041.

Balancing the cyclooxygenase portfolio.

CMAJ. 2006 May 23;174(11):1581-2. doi: 10.1503/cmaj.060471.

The sad story of Vioxx, and what we should learn from it.

Cleve Clin J Med. 2004 Dec;71(12):933-4, 936, 938-9. doi: 10.3949/ccjm.71.12.933.

引用本文的文献

Modelling of mouse experimental colitis by global property screens: a holistic approach to assess drug effects in inflammatory bowel disease.

PLoS One. 2012;7(1):e30005. doi: 10.1371/journal.pone.0030005. Epub 2012 Jan 18.

Should benefit-risk assessment have its own drug "label"?

Drug Healthc Patient Saf. 2011;3:37-41. doi: 10.2147/DHPS.S21927. Epub 2011 Aug 3.

Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy.

Drug Saf. 2008;31(7):609-16. doi: 10.2165/00002018-200831070-00006.

Captive subjects: pharmaceutical testing and prisoners.

J Med Toxicol. 2007 Mar;3(1):37-9. doi: 10.1007/BF03161037.