Clinical Research Educational Seminar |
CL-1 Measurement in clinical trials: Right scales for the right patients Sidney H. Kennedy There is growing concern that traditional approaches to antidepressant drug development need to be altered. Standard entrance criteria and measures in clinical trials have not effectively identified patients who respond at significantly higher rates to investigational drugs than to placebo. While this may be due to a true lack of efficacy for some new drugs, it may also reflect the relative insensitivity of standard rating scales. With the emergence of new drugs with different mechanisms of action and distinct clinical profiles, it is particularly important to have sensitive scales to detect therapeutic advantages over traditional antidepressants. Beyond new drug development, clinicians also should be aware of the methodologies to evaluate augmentation strategies and relapse prevention. This presentation will select examples of scales and methodologies to address measurement of rapid onset of action, neurocognitive effects, sexual dysfunction and functional outcomes.
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