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Ethical considerations concerning treatment allocation in drug development trials

Department of Epidemiology and Public Health, Department of Statistical Science, University College London, UK, stephens{at}public-health.ucl.ac.uk

It is claimed that much of the opposition to placebos is based on the misunderstanding that their use implies the withholding of effective treatments. It is also argued that the ethical feasibility of a trial must be judged by comparing the likely prognosis of patients in the trial to their expectations outside the trial. Furthermore, a longer-term perspective of the patients needs is necessary; the ethical dilemmas involved cannot be resolved at the point of sickness. Some device such as the ‘original position’ of the philosopher John Rawls is needed. Finally, it is argued that placebo run-ins involve a violation of consent and should be eliminated from clinical trials.

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