ISSUE NO. 1 — FDA Guidance Ensures New Drugs Are Studied for Their Potential to Impair Driving Ability

Reducing the incidence of motor vehicle accidents (MVAs) caused by drug-impaired driving is a public health priority. With more than 20,000 FDA-approved drugs on the market, many containing psychoactive or sedative ingredients, systematically identifying those that may impair driving is critical for safe and effective drug development.

The FDA guidance emphasizes pharmacological/toxicological, epidemiological, and behavioral assessments to determine potential drug-related driving impairment. Early trials previously relied on self-reported adverse cognitive effects, but the FDA now mandates direct measurement to ensure accurate evaluation. 

The inclusion of these assessments represents a dramatic shift in the design of early-phase studies as most only assessed self-reported adverse events related to cognition, while the guidance requires direct measurement of the effects.

In Issue 1 of The Altascientist, we look into the importance of evaluating drug effects on driving ability, including: 

• Driving Simulation Testing and CNS Side Effect Specificity
• Cognitive Studies With State-of-the-Art Driving Simulator
• Regulatory Recommendations and Requirements
• Case Studies

Performing Cognitive Clinical Studies With State-of-the-Art Driving Simulators

Reducing the incidence of motor vehicle accidents (MVAs) that occur because of drug-impaired driving is a public health priority. There are more than 20,000 FDA-approved drugs on the market currently, many of which contain psychoactive or sedative pharmaceutical ingredients which could alter the ability to operate a motor vehicle. Systematically identifying drugs that may increase the potential for MVAs is a critical component in safe and effective drug development.

With 10 simulators permanently installed on-site, and capacity for 10 more, Altasciences has partnered with Cognitive Research Corporation (CRC) to provide sponsors with an advanced driving simulator study solution. These simulators generate highly accurate driving performance data comparable to over-the-road testing, but in less time, at lower cost, and with no safety risks. They are also used to assess the effects of age, trauma, neurological disease, alcohol, and fatigue on driving performance.

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