Clinical trials involving the central nervous system (CNS) require a high level of clinical expertise due to their complex nature. CNS drug trials require specific processes in areas such as participant eligibility and operational conduct. One of the critical areas that must be analyzed in CNS clinical trials is cognitive testing using a driving simulator. With cars and other vehicles being such a ubiquitous aspect of the modern world, it is vital to test the effects of CNS drugs on a participant’s ability to drive. When conducting clinical trials, it’s important to partner with a contract research organization (CRO) with access to the tools to do just that. Here’s why.
What Are CNS Trials, and What Does Driving Have to Do with Them?
In recent years, driving simulation studies have been required for any drug that could affect cognition. Many CNS drugs fall into this category. CNS clinical trials can be applicable for a variety of different special populations. From sleep categories like insomnia, sleep apnea, and delayed sleep phase syndrome to pain groups like migraine, sports injury, and fibromyalgia. When your company conducts first-in-human clinical trials, all new drugs should be tested to see how they affect the central nervous system. Due to their intricacies, these CNS clinical trials require teams with both therapeutic and technical expertise. As one of the required aspects of these trials, a team that can provide your trials with access to a driving simulator is essential.
How a Clinical Driving Simulator Works for Your Study
A driving simulator used in CNS clinical trials must be high-quality and meet the regulations set for these types of trials. The simulator should be able to accurately test both therapeutic and adverse drug effects while the user is driving. It should also feel like on the road driving with realistic 3D graphics that represent the driving environment. From a vehicle dashboard to the roadway and scenery, the simulator should accurately test the participant’s driving abilities. The simulator should also provide auditory feedback and steering sensitivity for an authentic driving simulation. Plus, the simulator should automatically measure psychomotor functioning, divided attention, and situational awareness as the user drives. All these aspects are important to help your team evaluate the cognitive effects of the drug you are testing.
Partnering with a CRO for Clinical Trials and Driving Simulation
When you are looking for a partner for early clinical development and CNS clinical trials, it is important to work with a CRO that understands the complexities of these trials. Your CRO partner should have experience with the complexities of CNS trials, including driving simulation. They should also have dedicated research physicians who can help guide participants through the trials. Access to state-of-the-art driving simulators can help make following regulations for your CNS clinical trials more efficient and const-effective. Your chosen CRO should also have driving studies designed and conducted that meet regulatory requirements, complete with full-certified driving simulation study specialists to assist with the simulation.
About Altasciences
Altasciences is a mid-sized contract research organization and drug development solution your company needs for your next drug development project. This integrated CRO with pharmaceutical CDMO services offers partners over 25 years of research experience for preclinical studies and clinical trials. Altasciences has developed an innovative approach that companies in the pharmaceutical and biotechnology industries have come to rely on. Plus, partners gain access to the Altasciences team’s expertise in a wide variety of study types and therapeutic indications. This includes experience in early clinical development and CNS clinical trials. Partners are able to utilize Altasciences’ resources, including over 580 beds, access to an experienced, Phase 1 clinical trial units, highly trained staff, and a recruiting database of more than 400,000 potential participants. Partner with this trusted CRO/CDMO for all your early clinical development needs.
See how Altasciences can help you conduct driving simulations at https://www.altasciences.com/
Original Source: https://bit.ly/3uKy0F6
