Placebo-controlled trials and the Declaration of Helsinki

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...

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Bibliographic Details
Published in:The Lancet (British edition) 2002-04, Vol.359 (9314), p.1337-1340
Main Authors: Lewis, John A, Jonsson, Bertil, Kreutz, Gottfried, Sampaio, Cristina, van Zwieten-Boot, Barbara
Format: Article
Language:English
Subjects:
Active control
Bioethics
Biological and medical sciences
Clinical trial. Drug monitoring
Clinical trials
Clinical Trials as Topic - methods
Developing countries
Ethics
Ethics, Medical
General pharmacology
Helsinki Declaration
Humans
Informed consent
LDCs
Medical ethics
Medical research
Medical sciences
Patients
Pharmacology. Drug treatments
Placebos
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Summary: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.
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(02)08277-6