Clinical Trials on Driving Fitness and Ability under medicinal drugs become more and more important to maintain mobility and improve traffic safety:

• The acquired information can help physicians to choose a drug causing the least impairment of driving fitness from therapeutically equivalent substances.
• It can support patients to optimize their mobility by supplementing package inserts (e.g. about dose dependence or duration of impairment).
• For producers appropriate studies offer the opportunity to prove superiority over competing substances and to avoid or attenuate warning notices.

WIVW provides support in planning, implementing, evaluating and publishing ICH/GCP clinical studies on the influence of various medications and diseases on the ability to drive. Depending on the research question being addressed, epidemiological field trials or experimental studies are carried out. For this purpose, several simulators at different stages of development, diagnostic equipment for testing various driving-related performance tasks (recognized by FeV), applications for smartphones and tablet PCs, standardized test tracks in real traffic and several instrumented vehicles are available.

The benefits of clinical trials with WIVW driving simulation systems include:

• risk-free, highly standardized investigation of driving performance;
• representative test scenarios with empirically documented sensitivity to a variety of neurological disorders and psychoactive substances;
• a selection of endpoints for evaluating driving ability according to a performance profile based on traffic psychology.

The applied methodological approach developed by WIVW has been validated in an extensive alcohol calibration study published in the Journal of Clinical Psychopharmacology (Driving Performance Under Alcohol in Simulated Representative Driving Tasks) and awarded with the German Traffic Safety Award of the Federal Highway Research Institute 2012 (2^nd Place) as well as with the Best Poster Award of the Annual Meeting of The International Society for CNS Clinical Trials and Methodology in Washington in February 2013.

You can find more information about clinical trials here.