Placebo Controlled Clinical Trials are as Ethical as Active Controlled Trials Even if Effective Therapies Exist
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0092-8615/2002 Copyright 0 2002 Drug Information Association Inc.
PLACEBO CONTROLLED CLINICAL TRIALS ARE AS ETHICAL AS ACTIVE CONTROLLED TRIALS EVEN IF EFFECTIVE THERAPIES EXIST YEONG-LIANG LIN, MD, HERNG-DER CHERN,MD, AND MONG-LING CHU, MD Reviewers, The Center for Drug Evaluation, Taipei, Taiwan
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. Key Words: Placebo controlled trials; Ethical; Subjects; Declaration of Helsinki
IN RECENT YEARS, ethics committees and investigators have often begun to consider placebo controlled clinical trials to be unethcal if effective therapies are available when the trials are conducted. This concept was further strengthened by the 2000 revision of the Declaration of Helsinki (I), which states that: “The benefits, risks and burdens of a new method should be tested against those of the best current therapeutic methods.” However, because of substantive debate regarding the controversial additions to the revised Declaration of Helsinki (2,3), the World Medical Association subsequently clarified its position on the use of placebo controlled trials. This article further discusses why placebo controlled clinical trials can be considered as ethical as active controlled trials, even if effective therapies are
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available for the medical conditions concerned. In determining whether it is ethical o r unethical to conduct placebo controlled trials under such circumstances, it is worth scrutinizing the process of clinical trials. Before the subjects are enrolled, informed consent must be obtained. In this process, the possible randomization of some subjects to placebo arms and the potential risks due to the lack of active treatments during the trial period are explained both verbally and in written forms. The informed consent process is the same regardless of whether the trial is placebo controlled or active controlled. Although there are known limitations of our consent forms, as long as they are completed according to the ethical principles described in the Declaration of Helsinki and the International Conference on Harmonisation E6 Good Clinical Practice (4), the consent forms may in themselves constitute an ethical cover. Thus, placebo controlled trials may be ethically conducted provided that subjects are fully
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Yeong-Liang Lin, Herng-Der Chern. and Mong-Ling Chu
informed about the risks of entering clinical trials and the consequences due to the lack of active treatment during the trial period. Second, when we
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