Driving as a Functional Endpoint

Driving as a Functional Endpoint

Driving performance is gaining attention as a danger to consumers of anti-histamine, benzodiazepine, anti-depressant and other medications with residual effects. The FDA and NHTSA (National Highway Transportation Safety Administration) have issued statements about developing mandatory protocols to assess driving-impairment risks of a variety of drugs. How can a sponsor be sure that their drug – in development or already marketed – will not affect driving?

Cognitive Research Corporation, a CRO with specialized expertise in CNS indications and cognition, has an exclusive partnership with the University of Iowa to employ their proprietary MiniSim PC-based driving simulators in clinical trials for the pharmaceutical, food and beverage industries. Gary Kay, Ph.D. neuropsychologist and President of Cognitive Research Corporation, says that these new high-fidelity driving simulators make it possible to conduct driving studies in “half the time, at half the cost and with equal sensitivity” compared to other approaches used for studying drug impaired driving.

Dr. Kay is available to discuss regulatory agency guidance, simulator study design and cost-effective use of their MiniSim technology in driving assessment. He has published on the subject and was co-author of the National Highway Transportation Safety Administration’s proposed protocol for studying drug-impaired driving.  The NHTSA report is available at (web address).  A recent MedScape interview with Dr. Kay on this topic can be seen here. Please contact Bobbie Theodore at 916 939 6696 clinicaltrials@btheodore.com for more information or to arrange a conversation with Gary Kay, Ph.D.