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November 6, 2002

The Ethics of Underpowered Clinical Trials

JAMA. 2002;288(17):2118-2119. doi:10.1001/jama.288.17.2118

To the Editor: I have a number of concerns about the article by Mr Halpern and colleagues.1 First, much of their argument is based on "exposure of participants to the risks and burdens of human research." On the contrary, I believe that RCTs should be carried out when there is equipoise; ie, when the treatments being compared are equally likely to be beneficial. Randomized trials under this condition (at least when the comparator treatments are otherwise widely available) simply extend the patient's choice.2 The premise that patients somehow make a sacrifice for the common good when they participate in a trial is therefore wrong.

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