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P185 Background and Purpose — The results of  phase III trials of neuroprotective drugs for acute ischemic stroke  have been disappointing. We examine the question of whether these  trials may have been underpowered.Methods — Computer  simulations were based upon the binomial distribution.Results — We  illustrated that even small overestimates of the efficacy of an  intervention can lead to a serious reduction in statistical power, that  use of data from phase II studies tends to lead to such overestimation,  and that a minimum clinically important difference derived using  cost-effectiveness modeling techniques is considerably smaller than  might be suggested by intuition.Conclusions — We  recommend placing more emphasis on minimum clinically important  differences when planning stroke trials, with these differences being  derived from an assessment of public health impact obtained in  conjunction with the use of epidemiologic and cost-effectiveness  models. Even small benefits, when averaged over a sufficiently large  number of cases, will, in total, accrue to a large positive impact on  the public health.

Have Randomized Controlled Trials of Neuroprotective Drugs Been Underpowered?: An Illustration of Three Statistical Principles