Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues

@article{Temple2000PlaceboControlledTA,
  title={Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues},
  author={R. Temple and S. Ellenberg},
  journal={Annals of Internal Medicine},
  year={2000},
  volume={133},
  pages={455-463}
}
Placebo-controlled trials are used extensively in the development of new pharmaceuticals. They are sometimes challenged as unethical in settings in which patients could be treated with an existing therapy (1-7). The issues of when placebo controls are ethically acceptable and when they are scientifically necessary are important and worthy of discussion. The Ethics of Placebo Controls The Declaration of Helsinki The Declaration of Helsinki (8) is an international document that describes ethical… Expand
Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 2: Practical Issues and Specific Cases
TLDR
It is concluded that placebo controls are ethical when delaying or omitting available treatment has no permanent adverse consequences for the patient and as long as patients are fully informed about their alternatives. Expand
Are Placebo-Controlled Clinical Trials Ethical or Needed When Alternative Treatment Exists?
  • R. Simon
  • Medicine
  • Annals of Internal Medicine
  • 2000
TLDR
Temple and Ellenberg argue that placebo-controlled trials may be ethically conducted when effective therapy exists as long as omission of such treatments would not increase risk for death or irreversible morbidity and patients are fully informed about their alternatives. Expand
Placebo-controlled trials of new drugs: ethical considerations.
TLDR
Without a placebo control, one cannot always tell whether a new drug that is not as effective as existing therapy is still sufficiently more effective than placebo to justify its use. Expand
Are placebo‐controlled trials ethical in areas where current guidelines recommend therapy? No
TLDR
The latest revision of the Declaration of Helsinki in 2000 introduced more conservative indications on the use of placebo in randomized trials and pharmaceutical companies are driven by the FDA and EMEA/CPMP requirements to propose placebo-controlled trials. Expand
The ethics of placebo-controlled trials--a middle ground.
TLDR
It is argued that placebo-controlled trials are permissible when proven therapies exist, but only if certain ethical and methodologic criteria are met, and that there are serious problems with placebo orthodoxy. Expand
The ethics of placebo-controlled trials: methodological justifications.
TLDR
Key considerations are set out relevant to considering whether methodological reasons for a placebo control are compelling, which are essential to assessing the ethics of placebo controls in these controversial last two cases. Expand
MÉDICALE / MEDICAL ETHICS ON THE ETHICS OF PLACEBO-CONTROLLED TRIALS
The most classical form of clinical trials entails the inclusion of both intervention and comparison groups. If the choice of the intervention agent is expected to be the novel therapy (whether a newExpand
Empirical evidence against placebo controls
TLDR
The evidence presented in this paper suggests that the Declaration of Helsinki be reconsidered, and perhaps revised, in light of actual practice, and what clinical investigators believe to be ethically acceptable. Expand
Scientific and Ethical Issues in the Use of Placebo and Active Controls in Clinical Trials
  • S. Ellenberg
  • Medicine
  • Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research
  • 2003
TLDR
Clinical trials to determine whether an investigational treatment is effective and safe for its intended use are performed, and non-inferiority studies are often inadequate to support conclusions that a drug is effective. Expand
Ethical Concerns in Placebo-Controlled Studies: An Analytical Approach*
TLDR
A checklist to assist IRBs in the evaluation of placebo-controlled studies is designed and tested in IRB meetings and modified to better reflect the needs expressed in the discussions. Expand
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References

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TLDR
It is concluded that placebo controls are ethical when delaying or omitting available treatment has no permanent adverse consequences for the patient and as long as patients are fully informed about their alternatives. Expand
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The antiemetic ondansetron was used to explore the value of active controlled trials for two reasons: Firstly, the ethics of using placebo controls in ondANSetron trials has been questioned repeatedly, and secondly, the efficacy of an intervention and its likelihood of causing harm have to be determined. Expand
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This paper will review the specific issues in trials for short term peptic ulcer disease, demonstrating that controlled trials utilizing placebo are worthwhile, are safe, offer distinct advantages over alternative trials, and impose no real ethical conflict. Expand
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