Driving Simulators in Clinical Research
April 20,2015 Lorraine Rusch

Driving is a complex motor skill involving many perceptual, physical and cognitive activities. Many of us routinely observe drivers on the road that are distracted, aggressive or are simply not skilled. Additionally, people with underlying diseases may also contribute to impaired driving ability as a result the medication they may be taking.Senior man at the wheel

The number of Americans currently taking prescription medication is staggering. Many of these are psychoactive or sedating drugs, which could also affect the driver’s ability to operate a motor vehicle. With the objective of lowering the incidence of drug-related Motor Vehicle Accidents (MVAs), the FDA has recently proposed the evaluation of all new drugs under the recently released draft guidance entitled “Evaluating Drug Effects on the Ability to Operate a Motor Vehicle Guidance for Industry,” issued January 2015.

This guidance outlines considerations in a tiered approach for the evaluation of potentially CNS-acting drugs in both healthy normal volunteers and the intended patient populations, mostly those receiving chronic doses. Additionally, drugs that may have residual daytime effects after nighttime administration are clear targets (i.e. sleep aids) as are those that are thought to improve CNS skills but have off-target effects that might actually increase the likelihood of driving impairment. These evaluations are also used to assess impairment in already approved drugs where changes in indication, dosing schedule or patient population could create a driving impairment hazard previously not elucidated.

Early Development Clinical Pharmacology Studies

FDAThe FDA guidance places the focus of data gathering during early development phase I/II clinical pharmacology studies. The radical change proposed in this guidance would be that ALL early stage trials would need to evaluate cognitive function within the protocol. This will be a major change for most sponsors. Adverse events in these smaller sized studies (cohorts can typically be comprised of 6 active and 3 placebo or some variation thereof) can indicate a need for intense monitoring in later studies.

The new guidance makes it clear that perceived driving ability by patient reported outcome has been proven to be significantly inadequate – hence the need for a formal driving assessment.

As the majority of data suggests the potential for impairment, dedicated driving studies are warranted. These studies are sometimes carried out in motor cars but more commonly conducted on driving simulators. Generally the exposure-response relationship between the drug concentrations (and/or metabolites) on driving test endpoints provides a useful interpretation for these studies.

Specialized Clinical Pharmacology Facilities

Vince & Associates Clinical Research and its sister organization, Algorithme Pharma, are well positioned to provide driving simulator studies to the global pharmaceutical environment.  In order to be successful, these studies require specialized study recruiting, highly trained/certified employees and a strictly controlled clinical environment. We have an in-house professional advertising and marketing team, and our facilities were designed for optimum recruitment and retention of special populations in early development studies.

Both Vince & Associates and Algorithme Pharma collaborate with Cognitive Research Corporation to provide sponsors with a state-of-the-art driving simulator solution to test the impaired effects of a wide variety of drugs on driving abilities in both healthy and patient populations. The driving simulation units consist of 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.

To talk to one of our expert staff about these highly specialized studies please contact us by clicking the photo above.

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