In recent years, placebo controlled clinical trials have often been considered unethical if effective therapies are available when the trials are conducted. This concept was strengthened by the 2000 revision of the Declaration of Helsinki. This article discusses why placebo controlled clinical trials can be considered as ethical as active controlled trials, even if effective therapies are available for the medical conditions concerned.
World Medical Association.The Declaration of Helsinki. (www.wma.net).
2.
VastagB.Helsinki discord? A controversial declaration. JAMA.2000;284:2983–2985.
3.
BrennanT.Proposed revisions to the Declaration of Helsinki—will they weaken the ethical principles underlying human research?N Eng J Med.1999;341:527–530.
4.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.ICH Harmonised Tripartite Guideline: Good Clinical Practice (E6).Geneva, Switzerland; International Conference on Harmonisation: 1996.
5.
LuriePWolfeSMUnethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Eng J Med.1997;337:853–856.
6.
McCarthyM.US company's plan for trial in Latin America draws fire. Lancet.2001;357:691.
7.
TempleREllenbergS.Placebo-controlled trials and active-controlled trials in the evaluation of new treatments. Ann Intern Med.2000;133:455–463.
8.
EllenbergSTempleR.Placebo-controlled trials and active-controlled trials in the evaluation of new treatments. Ann Intern Med.2000;133:464–470.
9.
LevineRJThe use of placebos in randomized clinical trials. IRB.1985;7:1–4.
10.
PledgerGHallDBActive control equivalence studies: Do they address the efficacy issue? In: PeaceKE, ed. Statistical Issues in Drug Research and Development.New York: Marcel Dekker; 1990:226–238.
11.
FlemingTREvaluation of active control trials in AIDS. J Acquired Immune Defic Syndr.1990;3(Suppl 2):S82–87.