【摘 要】
：
To conduct a confirmatory drug trial, it is crucial not only to select primary endpoint(s) that can provide a measure of clinical benefits, but also to formulate appropriate decision rules based on th
【机 构】
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FDA/CDER/OB/DBI, USA
【出 处】
：
第五届21世纪中美医学论坛(The 5th Sino-US Symposium on Medicine in the 2
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To conduct a confirmatory drug trial, it is crucial not only to select primary endpoint(s) that can provide a measure of clinical benefits, but also to formulate appropriate decision rules based on these endpoints that may lead to potential efficacy claims.In this talk, some commonly used primary endpoints for major neurological drug indica tions, such as Alzheimer, stroke, Parkinson, seizure, migraine, and insomnia, will be described.The relevant clinical decision rules for these indications will be illustrated by examples.Most of these decision rules will involve muultiple comparison procedures.Statistical methods for control type Ⅰ error rates will be discussed.In neurology drug trials, in addition to functional measurements as primary endlpoints, mortality often occurs and is an important efficacy measure.A mixture model that handles both functional and mortality data will be discussed.In the model, functional measure and mortality are considered as a single endpoint with a mixture of outcomes.Clinical interpreta tion of the statistical analysis results of the model will be suggested.Finally, a recent development on the use of historical control in seizure monotherapy trials will also be discussed.
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