Is It Possible to Claim Efficacy if One of Two Trials is Significant While the other Just Shows a Trend?
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TL;DR
It is shown that it is possible to select the type I errors that enable the individual trials to achieve this goal without a substantial increase in the overall type I error.
Abstract
This note explores the possibility of allowing an efficacy claim for a new drug based upon the results of two pivotal clinical trials if one trial is significant in the usual sense while the other just shows a trend in the right direction. We show that it is possible to select the type I errors that enable the individual trials to achieve this goal without a substantial increase in the overall type I error.