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The ethics of tiny trials

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In the first issue of Archimedes we looked at evaluating the difference between a trial which showed therapeutic equivalence, and one which failed to show a difference between treatments. With the concentration on lack of answers in this edition, we turn to the ethics of trials.

It is commonly believed that a trial is justified if the clinician honestly does not know whether a study’s treatment is likely to be beneficial for the patient in front of them (equipoise). This position can only really be achieved after a thorough systematic review of any existing literature on the subject. Patients should be aware of the risks and benefits of the study, and make an active informed decision to become involved. Any trial which shows an effect, be that positive or negative, can be said to have assisted understanding and the care of others. When a study is too small to be able to give a conclusive answer, it merely places some patients at risk of adverse effects, others may be denied an advantageous therapy, and both have been deceived into believing their efforts will help other patients. Such studies waste resources (not least the time of the investigators) and may muddy the waters surrounding the therapy with claims of “no effect was shown”. As has been previously asserted,1 ethics committees should discard trials too small to show an effect.

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  • Bob Phillips

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