Algorithme Pharma and Cognitive Research Corporation (CRC) have partnered to provide sponsors with a state-of-the-art driving simulator study solution to test the impairing effects of a wide variety of drugs on driving abilities in both normal and patient populations. The simulator provides accurate driving performance data comparable in sensitivity to over-the-road-testing — in less time, for less money, and without the crashes. The customized driving simulator can also be used to evaluate the effects of age, trauma, neurologic disease, alcohol and fatigue on driving performance.
For their first driving simulation study last summer, Algorithme’s Montreal clinical unit was reconfigured to accommodate nine impressive driving simulation units which consist of three networked personal computers, high-fidelity driving controls, and use of multiple, linked video monitors that provide a wide field of view to maximize subject immersion and realism. The driving scenarios developed for the simulators were designed to assess a range of psychomotor, divided attention and cognitive tasks involved in driving. To ensure accurate study data, secluding participants in a room free of all potential distractions and interruptions was key. Drivers navigated various routes at all times of the day and night and were confronted with a variety of real-life situations, such as traffic and impromptu changes in road conditions.
"In total, 83 female participants were enrolled in the trial in less than 4 weeks. The study was a complex design, involving multiple doses, 2 inpatient stays per period and 4 treatment periods. Each participant was required to complete 18 driving simulations, ranging from 20 to 60 minutes over the course of the study, along with assessments of cognitive function and sedation.
In just over 3 months, the entire trial was completed successfully, generating over 1,500 drives for analysis at CRC. The units ran 24/7 during this time in order to accomplish this goal within our client’s timeline. None of this would have been possible without the close collaboration with CRC, their scientific expertise and dedication to client service.
Assessing the potential for next-day driving impairment of Flibanserin
Algorithme Pharma is proud to have partnered with Cognitive Research Corporation to evaluate the sedation-related safety of Flibanserin in premenopausal women. A research study sponsored by Sprout Pharmaceuticals.Request the poster >>
To our knowledge, no other CRO worldwide has the capacity to run a study of this magnitude within such a short timeframe – we are extremely proud of this. CRC is the only simulator provider that should be considered – they are head and shoulders above the rest", says Ingrid Holmes, Vice President, Clinical Operations.
It is reassuring to our sponsors that CRC works as an extension of Algorithme Pharma on driving studies; both CROs share a strong focus on quality, timelines and customer service. Both strive to provide reliable and well-designed studies that meet or exceed client expectations and are able to provide flexible solutions with little lead time.To request more information >>
Since 2013, there has been a noticeable increase in the information provided by the Food and Drug Administration (FDA) on the effects of prescription and over-the-counter medication on driving, such as allergy medications and sleep drugs. More and more, the FDA demands that certain drugs be tested for impairing effects and, given the long lead time on such studies, sponsors may not know of the requirement until the final stages of drug development.
- Several simulator scenarios have proven to be highly sensitive to both therapeutic and adverse drug effects.
- The simulator utilizes advanced three-dimensional (3D) graphics to generate realistic representations of various driving environments. The visual environment includes the vehicle dashboard, roadway, horizon, secondary task displays, intersections, traffic control devices and interacting traffic.
- Steering sensitivity is adjusted as a function of vehicle speed.
- Auditory feedback is provided for engine speed, acceleration limits, and for indication of excessive cornering speed, or excessive deceleration when braking.
- It provides automated measurements of psychomotor functioning, divided attention, situational awareness and other cognitive behaviors.
- CRC has developed equivalent versions of various driving simulation tasks (scenarios) that allow for re-testing while minimizing practice effects.