详情

Examine Clinical Research Evaluating Drug Effects on Behavioral Performance Tests

项目名称：	Examine Clinical Research Evaluating Drug Effects on Behavioral Performance Tests
摘要：	In 2016 the National Highway Traffic Safety Administration (NHTSA) funded research to demonstrate the Tiered Assessment Protocol by performing a full evaluation of the two drugs (cannabis and Alprazolam). In 2017 the US Food and Drug Administration (FDA) Center for Drug Evaluation Research developed guidance that provided nonbinding recommendations for drug development researchers to evaluate the risk of impaired driving using a tiered assessment protocol identical or similar to the one developed by the expert panel. For the current project, NHTSA seeks to perform a scoping review of the research designs, procedures, and results of clinical drug studies that employed the Tiered Assessment Protocol to examine how drug researchers are implementing the FDA guidance for evaluating drug effects on operating a motor vehicle. This project will perform a scoping review of clinical studies evaluating the potential impairing effects of over-the-counter and prescription drugs on behavioral performance tests (including driving). This project also will summarize the quantity and quality of the available clinical studies, by discussing study designs and results, how researchers implemented the 2017 FDA guidance, and how they employed the Tiered Assessment Protocol and/or similar protocols to evaluate the drugs.
状态：	Active
资金：	284563
资助组织：	National Highway Traffic Safety Administration
项目负责人：	Smither, DeReece
执行机构：	Battelle Memorial Institute
开始时间：	20190926
预计完成日期：	20230930
主题领域：	Highways；Research；Safety and Human Factors