Examine Clinical Research Evaluating Drug Effects on Behavioral Performance Tests

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.

Language

• English

Project

• Status: Active
• Funding: $284563
• Contract Numbers:

  DTNH2217D00033

  693JJ919F000187

• Sponsor Organizations:

  National Highway Traffic Safety Administration

  1200 New Jersey Avenue, SE
  Washington, D.C.  United States  20590

  Office of Behavioral Safety Research

  1200 New Jersey Avenue, SE
  Washington, District of Columbia  United States  20590
• Managing Organizations:

  National Highway Traffic Safety Administration

  1200 New Jersey Avenue, SE
  Washington, D.C.  United States  20590
• Project Managers:

  Smither, DeReece

• Performing Organizations:

  Battelle Memorial Institute

  505 King Avenue
  Columbus, Ohio  United States  43201
• Principal Investigators:

  Smither, DeReece

• Start Date: 20190926
• Expected Completion Date: 20231231
• Actual Completion Date: 0
• USDOT Program: Behavioral Safety Research
• Subprogram: Drug Impaired Driving

Subject/Index Terms

• TRT Terms: Behavior; Driver performance; Drugged drivers; Drugs; Evaluation; Literature reviews; Research projects
• Identifier Terms: U.S. Food and Drug Administration
• Subject Areas: Highways; Research; Safety and Human Factors;

Filing Info

• Accession Number: 01718736
• Record Type: Research project
• Source Agency: National Highway Traffic Safety Administration
• Contract Numbers: DTNH2217D00033, 693JJ919F000187
• Files: RIP, USDOT
• Created Date: Oct 3 2019 4:27PM