Transparency in drug regulation: mirage or oasis?
作者信息
Lexchin Joel, Mintzes Barbara
机构信息
Emergency Department, University Health Network, School of Health Policy and Management, York University, Toronto, Ont.
出版信息
CMAJ. 2004 Nov 23;171(11):1363-5. doi: 10.1503/cmaj.1041446.
Abstract
摘要
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本文引用的文献
1
Statement of the International Working Group on transparency and accountability in drug regulation.
Int J Risk Saf Med. 1996;9(3):211-7. doi: 10.3233/JRS-1996-9312.
2
Synthesising licensing data to assess drug safety.
BMJ. 2004 Feb 28;328(7438):518-20. doi: 10.1136/bmj.328.7438.518.
3
Evidence b(i)ased medicine--selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications.
BMJ. 2003 May 31;326(7400):1171-3. doi: 10.1136/bmj.326.7400.1171.
4
Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial.
JAMA. 2002 Jul 17;288(3):321-33. doi: 10.1001/jama.288.3.321.
5
Reporting of 6-month vs 12-month data in a clinical trial of celecoxib.
JAMA. 2001 Nov 21;286(19):2398-400.
6
Reporting of 6-month vs 12-month data in a clinical trial of celecoxib.
JAMA. 2001 Nov 21;286(19):2398; author reply 2399-400.
7
Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety Study.
JAMA. 2000 Sep 13;284(10):1247-55. doi: 10.1001/jama.284.10.1247.
8
Value of drug-licensing documents in studying the effect of postmenopausal hormone therapy on cardiovascular disease.
Lancet. 2000 Feb 12;355(9203):566-9. doi: 10.1016/S0140-6736(99)03432-7.
9
Impact of postmenopausal hormone therapy on cardiovascular events and cancer: pooled data from clinical trials.
BMJ. 1997 Jul 19;315(7101):149-53. doi: 10.1136/bmj.315.7101.149.
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