Copyright 2002 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.2002
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.
Janosky JE. The Ethics of Underpowered Clinical Trials. JAMA. 2002;288(17):2118-2119. doi:10.1001/jama.288.17.2118