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November 6, 2002

The Ethics of Underpowered Clinical Trials

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Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2002

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

To the Editor: Mr Halpern and colleagues1 argue that underpowered clinical trials are ethically justified only in 2 situations: (1) interventions for rare diseases in which investigators document explicit plans for including their results with those of similar trials in a prospective meta-analyses and (2) early-phase trials in the development of drugs or devices provided that they are adequately powered for defined purposes other than randomized treatment comparison.

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