Placebo-control led trials and the Declaration of Helsinki

被引:55
作者
Lewis, JA
Jonsson, B
Kreutz, G
Sampaio, C
van Zwieten-Boot, B
机构
[1] Hatch Green Cottage, Canterbury CT4 7LP, Kent, England
[2] Med Prod Agcy, Uppsala, Sweden
[3] Bundesinst Arzneimettel & Med Prod, Bonn, Germany
[4] Hosp Santa Maria, Lisbon Sch Med, Lisbon, Portugal
[5] Med Evaluat Board, The Hague, Netherlands
关键词
D O I
10.1016/S0140-6736(02)08277-6
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
A revised version of the Declaration of Helsinki, issued in October, 2000, remains a vital expression of medical ethics, and deserves unanimous support. A strict interpretation of the declaration seems to rule out clinical trials that use a placebo control group whenever licensed therapeutic methods already exist, preferring active controls. Although the efficacy of some new medicines can be satisfactorily established without the use of a placebo, for others the judicious use of placebo remains essential to establish their effectiveness.
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页码:1337 / 1340
页数:4
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