If you are performing CNS clinical trials, there is a good chance that you will need to determine the impact of the medication on a person’s driving ability. It’s common to test for this, and several methods have been developed over the years. If this is your first CNS trial, you may need to know about driving simulation trials and whether you should partner with a contract research organization (CRO) to perform the simulation. Here are some things you should know.
Why Should You Add Driving Ability Tests?
Preventing traffic accidents resulting from drug impairment is an important public health priority. This is where clinical trials come into the picture. Depending on where you hope to get drug authorization, you may need to perform driving simulation clinical trials. Countries like the United States might have restrictions on CNS drugs that could potentially impair driving. At the same time, Japan prohibits driving while on any medications known to affect the CNS, regardless of whether or not the drug has been shown to impact driving ability. If drugs that could affect our CNS are tested and shown not to impair driving, it is possible that broad restrictions can be eliminated in favor of less severe restrictions.
Real World Assessments for Accurate Data
There are a few ways to measure how a drug impairs driving ability during early clinical development. These include real-world on-the-road assessments, driving simulations, and neurophysical testing, including reaction times and psychomotor speed. Real-world assessment may not be feasible in evaluating drivers under all relevant conditions but is accurate for the evaluated set of conditions. It’s also expensive and time-consuming, and conditions such as weather, high traffic, and obstacles may make it difficult.
Neuropsychological Testing for Impairing Effects
Neuropsychological testing concerns variables such as visual perception, memory, and daytime sleepiness. It is helpful for early evaluations of potentially impairing or enhancing effects. The data can be used to rule out drugs that lack these impairing effects.
Driving Simulations for a Variety of Conditions
Driving simulations allow for testing in various conditions that may be hard to obtain in real-world assessments. It’s also less costly, safer, and faster. Driving simulations eliminate the risk for property damage or injury while still offering a high degree of validity. Conditions can be controlled and repeated. Simulations can also be combined with neuropsychological testing, resulting in the perfect mix of complementary information from both methods.
About Altasciences
Altasciences, a mid-sized drug development solution company, has more than 25 years of research experience. Altasciences has used an innovative approach to build a foundation that pharmaceutical and biotechnology companies have come to rely on. Clients are guided through the drug development process with tailor-made program roadmaps, from lead candidate selection to preclinical to clinical proof of concept, and beyond. Altasciences offers their partners expertise in various study types and therapeutic indications. Altasciences has key experience in CNS clinical trials, first-in-human clinical trials, and Ethnobridging. The CRO provides access to dedicated Phase 1 clinical trial units across North America in both the USA and Canada. Those resources include access to over 580 beds, a database with more than 400,000 potential participants, and a highly trained and experienced staff. Altasciences is the perfect choice for drug development for sponsors that need dedicated and integrated CRO/CDMO services.
Partner with Altasciences to perform driving assessments at https://www.altasciences.com/
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