Traffic Medicine Studies

Fitness to Drive and Medicines

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, interaction with alcohol etc.).
  • For producers appropriate studies offer the opportunity to prove superiority over competing substances and to avoid or attenuate warning notices.

In cooperation with our qualified partner WIVW (Wuerzburg Institute for Traffic Sciences) we provide support in planning, implementing, evaluating and publishing ICH/GCP clinical studies on driving fitness and ability. For this purpose, various driving simulators at different configuration stages (from essential to high-end) 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 well-founded endpoints for evaluating driving ability according to a performance profile based on traffic psychological expertise
  • full compliance with the Guidelines on Experimental Studies Undertaken to Determine a Medicinal Drug’s Effect on Driving or Skills Related to Driving of the International Council on Alcohol Drugs and Traffic Safety.

The applied methodological approach 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. Place; News Release of BASt) 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 (9th Annual Scientific Meeting).