Neuro Central hosted a free online webinar, ‘Drugs and Driving: Discussing the cognitive effects of drugs on driving performance’, featuring speakers Ingrid Holmes (Altasciences Clinical Research) and Gary G. Kay (Cognitive Research Corporation).
Following the webinar, our speakers took questions from the audience. Here, are the responses the those questions that we didn’t have time for during the live event. Do let us know your thoughts on drugs and driving or any of the questions posed by commenting below this feature!
Did you miss the live panel discussion? You can watch it On Demand here.
For one of our drugs under development, daytime sedation is being assessed as one of the study parameters. If it is found that the drug does not have any daytime sedation, will a driving simulation study be required?
In the absence of daytime sedation, assuming that it has been adequately assessed by tests of vigilance, complex attention, processing speed, and psychomotor functioning, it would be unlikely that you would be required to conduct a dedicated driving study.
What is simulator sickness?
One of the experts on simulator sickness, Robert S. Kennedy (Intl J of Aviation Med., 1993, 3(3):203-220) described this condition as a “by-product of modern simulation technology. Although it involves symptoms similar to those of motion-induced sickness (MS), simulator sickness (SS) tends to be less severe, to be of lower incidence, and to originate from elements of visual display and visuo-vestibular interaction atypical of conditions that induce MS.”
A small minority of individuals experience simulator sickness in our driving simulator. In the trials run at Altasciences it generally is <5% of participants screened. Certain types of driving scenarios, e.g., those involving multiple 90-degree turns, are more likely to induce simulator sickness. It is important to screen for simulator sickness and to exclude those individuals from clinical trials, as they are likely to experience adverse events which may bias the results of the study, and also preclude them to early withdrawal due to being unable to complete the driving tasks. It is also important to incorporate methods that mitigate against simulator sickness in the design of the simulator and the driving scenarios.
If a drug is known to cause sedation such as an opioid, will driving trial still be required?
A new compound, or an old compound with a new formulation, dose, or indication, which is known to cause sedation, is likely to require a dedicated driving study. If required, we can support you with agency interaction, but perhaps most importantly, we (CRC/Altasciences) have developed many agency accepted protocols. Working together with individuals experienced with designing these studies for FDA is key to a rapid review and limited change requests.
What is the predicted turnaround time for FDA protocol review?
In our experience, the turnaround time has been between 4 and 6 weeks. Generally that timeline is planned out during program development with the agency, but could also be considered a single request for the driving trial. If required, we can support you with the agency interaction, but perhaps most importantly, we (CRC/Altasciences) have developed many agency accepted protocols. Working together with individuals experienced with designing these studies for FDA is key to a rapid review and limited change requests.