Fifth revision of Declaration of Helsinki

BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7343.975 (Published 20 April 2002) Cite this as: BMJ 2002;324:975

Clause 29 forbids trials from using placebos when effective treatment exists

  1. J M Bland, professor of medical statistics
  1. Department of Public Health Sciences, St George's Hospital Medical School, London SW17 0RE
  2. Bournemouth Diabetes and Endocrine Centre, Bournemouth BH7 7DL

    EDITOR—I was delighted by the new clause 29 in the revised Declaration of Helsinki, which forbids clinical trials comparing drugs against no treatment when an effective treatment exists. I was dismayed that the World Medical Association was retreating from this position.1 From reading Hirsch and Guess's piece in the article about the latest revision of the Declaration of Helsinki, I am concerned that opposition from the pharmaceutical industry may lead to further revision.2

    I spent two years on a multicentre research ethics committee, which saw many proposals for trials of active versus no treatment. In some of these cases an effective treatment already existed. I think it wrong to ask people who have come seeking treatment to do without it for the sake of research. People come to doctors for help, not to act as …

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