Designing clinical trials for progressive conditions such as the psychosis of dementia is a complex task, fraught with clinical, statistical, and ethical dilemmas, and constrained by regulatory requirements. This presentation will focus on the factors that affect the choice of outcome measures in the design of clinical trials of antipsychotics for geriatric psychosis. Key concepts that underlie the selection of clinically meaningful outcomes will be identified. U.S. Food and Drug Administration regulatory requirements that influence study design, and their equivalent guidelines applied in other countries will be overviewed.
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