Placebo-controlled trials and the Declaration of Helsinki

@article{Lewis2002PlacebocontrolledTA,
  title={Placebo-controlled trials and the Declaration of Helsinki},
  author={John A. Lewis and B. Jonsson and G. Kreutz and C. Sampaio and B. V. Zwieten-Boot},
  journal={The Lancet},
  year={2002},
  volume={359},
  pages={1337-1340}
}
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… Expand

Topics from this paper

Placebo and the helsinki declaration — What to do?
  • B. Vrhovac
  • Medicine
  • Science and engineering ethics
  • 2004
TLDR
The Helsinki Declaration is the ‘gold standard’ — a directive on how to conduct controlled studies in humans in conformity with ethical principles, and some articles have remained unchanged in the most recent (sixth) revision of the Declaration. 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
Risk, Helsinki 2000 and the use of placebo in medical research.
TLDR
It is believed that minor levels of risk are justified in healthcare research under defined conditions provided there is full information and consent and the opportunities for altruism in research should neither be exploited nor prevented. Expand
A review of the ethics of the use of placebo in clinical trials for relapsing-remitting multiple sclerosis therapeutics.
TLDR
Randomized placebo-controlled clinical trials have been considered the most rigorous method of evaluating the efficacy of novel treatment interventions and a growing consensus has emerged that further inclusion of placebo arms in clinical trials of novel RRMS therapies is no longer ethical. Expand
Establishing efficacy of a new experimental treatment in the 'gold standard' design.
TLDR
This work addresses the necessary conditions in the gold standard design which allow the claim of efficacy for the new treatment with particular focus on assay sensitivity and the necessity of the a priori definition of what constitutes a clinically relevant difference in efficacy. Expand
Ethical aspects of placebo groups in pain trials
TLDR
A review of themes in the psychiatric research literature suggests possible strategies for analysis of this issue in the area of pain research. Expand
Study designs, duration, and choice of comparators including the use of placebo
TLDR
This paper discusses some methodological issues that are relevant to the design of controlled trials of new medicinal products for use in the treatment of schizophrenia, including the use of placebo. Expand
Ethics of placebo-controlled clinical trials in multiple sclerosis
TLDR
The group concluded that placebo-controlled trials can still be done ethically, with restrictions, for patients with relapsing MS, but should only be offered with rigorous informed consent if the subjects refuse to use treatments, have not responded to them, or if these treatments are not available to them for other reasons. Expand
Consent to open label extension studies: some ethical issues
TLDR
It is argued that patients invited to participate in open label extension studies cannot give a proper consent to such research unless they know to which arm of the main trial they were recruited. Expand
Placebo versus best-available-therapy control group in clinical trials for pharmacologic therapies: which is better?
  • M. Castro
  • Medicine
  • Proceedings of the American Thoracic Society
  • 2007
TLDR
Investigators should keep in mind that one should not sacrifice the scientific merit of a trial to include a best-available-therapy control group as long as the placebo control group poses little harm to participants and, importantly, the trial offers potential benefit to the subject. Expand
...
1
2
3
4
5
...

References

SHOWING 1-10 OF 12 REFERENCES
Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues
TLDR
It is concluded that placebo-controlled trials may be ethically conducted even when effective therapy exists, as long as patients will not be harmed by participation and are fully informed about their alternatives. 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
The continuing unethical use of placebo controls.
TLDR
In these times of raised ethical consciousness, placebo treatments are still commonly used in medical research in circumstances in which their use is unethical. Expand
Ethical issues in the design and conduct of clinical trials in developing countries.
TLDR
Ethical issues in the design and conduct of clinical trials in developing countries are discussed, focusing on phase 3 and other drug trials that, if successful, can lead to the use of drugs in these countries. Expand
Doctors revise Declaration of Helsinki
The World Medical Association (WMA) has sent out its strongest ever signal to pharmaceutical companies and research organisations around the world that rich populations should not exploit poorExpand
Short-term efficacy of tricyclic antidepressants revisited: a meta-analytic study
TLDR
It is concluded that tricyclic antidepressants are efficacious in the short-term treatment of major depression, however, the magnitude of the effect is rather modest. Expand
Trials to assess equivalence: the importance of rigorous methods
The aim of an equivalence trial is to show the therapeutic equivalence of two treatments, usually a new drug under development and an existing drug for the same disease used as a standard activeExpand
Research involving human subjects in developing countries.
TLDR
The research community and the public have been engaged in a reexamination of the ethics and responsible conduct of research involving human subjects for many years and attention has recently focused on research carried out in countries where the requirements for review, approval, and oversight are much less stringent. Expand
Beta blockade during and after myocardial infarction: an overview of the randomized trials.
TLDR
The aim has been not only to review the 65-odd randomized beta blocker trials but also to demonstrate that when many randomized trials have all applied one general approach to treatment, it is often not appropriate to base inference on individual trial results. Expand
Placebos on trial
...
1
2
...