Analysis of early phase and subsequent phase III stroke studies of neuroprotectants: outcomes and predictors for success

Clinical Trials Sunday, March 2nd, 2014

Experimental & Translational Stroke Medicine: February 7, 2014

Background

Efficacy of neuroprotective treatments for ischemic stroke was not convincingly demonstrated in clinical phase III trials so far, whereas some preceding early phase studies found neuroprotection to be beneficial. We aimed to determine the frequency with which phase III studies are preceded by positive early phase studies, and to identify characteristics of early phase studies that are associated with correct prediction of phase III studies.

Methods

We identified phase III studies and corresponding early phase studies of neuroprotective treatments for stroke. Data on study characteristics of early phase trials were extracted and compared between studies that were classified according to their results as “false positive” and “true neutral” using logistic regression analysis.  Read More

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