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document
The problem of measurement error in multisite clinical trials . The implementation of a multisite , randomized , clinical psychopharmacologic trial involves a substantial investment of time and effort on the part of all participants . Because of their complexity , such clinical trials present unique methodological and design challenges . Indeed , it is not uncommon for such studies to conclude with uninterpretable results , due in part to such methodological pitfalls . It has been suggested that clarification of such methodologic dilemmas is one of the most important challenges facing the future of industry-sponsored psychopharmacologic drug development . Among the many factors that may contribute to problematic clinical trial results , error in measuring the phenomena being studied is of particular concern . In this article , we describe the outcome of an intensive series of interrater reliability training sessions for the 17-item Hamilton Depression Rating Scale conducted at the start of a Phase II multisite clinical drug trial . The data underscore the magnitude of error present in such a test setting and provide preliminary evidence for the potential effect of this problem on the detection of clinical change .
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Intervention_Educational
intensive series of interrater reliability training sessions
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Intervention_Psychological
17-item Hamilton Depression Rating Scale
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Outcome_Mental
Hamilton Depression Rating Scale