Driving Trials–A Safer Alternative
Using Driving Simulators in Clinical Trials
If you are developing a psychoactive drug, it may require a driving trial to evaluate its effects on the ability to operate a motor vehicle, as per the FDA’s guidance document.
Drugs intended for chronic (including chronic-intermittent) outpatient use by adults are most likely to need evaluation of effects on driving ability. In contrast, drugs limited to use in young children or to use in hospital inpatient settings would not need such evaluation
Evaluating Drug Effects on the Ability to Operate a Motor Vehicle USFDA November 2017Altasciences offers a fast, safe alternative to on-the-road driving trials, with no risk of property damage or personal injury. We have conducted over 13,000 simulated drives in support of drug development.
Driving simulation trials provide all the data you need for regulatory approval, and the trial data we provided for the approval of flibanserin in premenopausal women has been described as “reassuring” by the FDA.
Consult our Driving Simulation Fact Sheet
Specialized Expertise and Facilities for Driving Simulation Trials
Our comprehensive driving simulation solution delivers reliable data for your drug development program, thanks to:
- 12 driving simulators permanently installed on-site for rapid study start-up;
- our long-term partnership with Cognitive Research Corporation to use their proprietary driving simulators;
- our experience — we have completed over 13,000 simulated drives to date;
- our expertise in analyzing impaired driving, at peak exposure and/or during the residual effect seen the morning after evening dosing; as well as
- our extensive database of healthy normal volunteers, special populations, and patients.
Benefit from accurate driving performance data comparable in sensitivity to over-the-road testing, with:
- Faster study startup
- Lower cost
- No risk of property damage
- No risk of injuries
The CRC driving simulator has proven sensitivity to the effects of
- Age
- Trauma
- Neurological disease
- Drowsiness
- CNS depressants
- CNS stimulants
How Driving Simulation Trials
Inform Drug Development
Did you know? Regulators around the world accept data from both on-the-road and simulator driving testing, and an open IND is not required to start your driving simulator trial. We can provide driving simulation data regardless of your location or the status of your drug development program. Our work is driven by your needs.
As driving data informs your label, a driving trial that shows no impact on driving ability may be a strategic advantage. Whether your study is pre-planned, or has been requested by regulators during your program, we are ideally suited to deliver reliable results, fast.
Case Study: Driving Simulation Trial for Flibanserin (Addyi)
Altasciences demonstrated that there was no impairment to driving the morning after nighttime dosing of flibanserin in premenopausal women. The study, sponsored by Sprout Pharmaceuticals, was described as “reassuring” by the FDA.
Rapid Study Start-Up for Driving Simulation Trials
Are you on a tight timeline for your driving simulation study? Let us get your study up and running swiftly with dedicated, on-site driving suites, highly experienced staff, and rapid recruitment.
Our streamlined processes enable rapid trial start-up, allowing us to initiate projects with impressive speed and efficiency.
By streamlining contract execution, regulatory document preparation, and participant recruitment, we efficiently produce relevant clinical trial results. Having 12 simulators permanently installed on-site in dedicated suites eliminates installation and set-up time. Our strong project management, combined with a dedicated internal clinical team and collaborative relationships with sponsors, means we can get your driving simulation trial up and running within a short timeline.
Recruitment for Driving Simulation Studies
We excel in recruiting participants for driving simulation trials. With a large pool of over 40,000 healthy normal volunteers, special populations, and patients, we rapidly recruit and enroll. We have partnerships with hospitals and management of independent investigational sites to further enhance our recruitment efforts. Our recruitment strategies and database ensure we meet enrollment targets and your study progresses without delays.
Key Advantages of Our Recruitment Strategy
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Our dedicated recruitment team and streamlined processes ensure a quick turnaround from protocol approval to participant enrollment, keeping your driving simulation studies on track. |
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We perform a thorough assessment for driving simulator effects to ensure that participants recruited do not suffer from cybersickness or simulator sickness. |
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Our well-established databases allow us to pre-identify study participants and perform targeted outreach. With access to many demographics, ethnicities, special populations, and patients, we can efficiently predict recruitment timelines. |
Our approach to recruitment, combined with our innovative strategies and large participant pool, ensures that your trial reaches its enrollment targets quickly, maximizing study deliverables and data integrity.
Turnkey Solutions for Driving Simulation Trials and Early-Phase Studies
We save you time and simplify the process with a turnkey solution for conducting driving simulation studies, handling every aspect of your trial from start to finish. For studies involving controlled substances or positive controls, we hold the required narcotic licenses, helping you avoid regulatory delays and start your trial without interruption.
With three clinical pharmacology units and co-located bioanalytical laboratories in the U.S. and Canada, we provide dual regulatory pathways—Investigational New Drug (IND) and Clinical Trial Application (CTA). Our focus on efficiency ensures rapid start-up and streamlined timelines for your clinical trial.
Protocol review/writing:
Whether starting de novo or refining an existing protocol, our team of clinical experts will streamline the process to support informed decision-making and meet critical study milestones.
Clinical conduct:
Our in-house driving suites, with 12 simulators, are permanently installed and staffed by highly experienced assessors.
CRA/Clinical monitoring:
Timely tracking of pharmacokinetic (PK) and pharmacodynamic (PD) data, safety assessments, and adverse event reporting, to ensure compliance with regulatory requirements and maintain data integrity throughout the trial.
Bioanalytical services:
Our state-of-the-art, co-located bioanalytical labs are equipped with a wide range of methods and assays, ensuring precise and timely PK data, biomarkers, and others as appropriate. Leveraging these established methods, we provide the reliable data you need to meet regulatory standards, enabling faster decision-making and providing comprehensive label information.
Data Services and Reporting:
We handle data management, analysis, and comprehensive reporting to deliver timely, high-quality results, ready to support your regulatory submissions.
Regulatory Consulting:
Need support navigating regulatory requirements for your driving study? Our experts can assist with a detailed plan.
At Altasciences, we’re fully equipped to ensure your driving simulation studies are completely and quickly enrolled, and delivered on time.
Driving Simulation Trials—Case Studies and Resources
FAQ
What are driving simulation trials used for in drug development?
The FDA uses driving simulation trial data to assess how drugs affect a person's ability to drive. These trials are required for drugs that may impact cognition or the central nervous system (CNS).
Driving simulation studies are used in several ways:
- Drug development: Driving simulation trials are used to evaluate the effects of drugs on driving performance during the early stages of clinical development.
- Drug labeling: Driving simulation trials help collect data for a drug's label.
What are the benefits of using driving simulators over real-world driving tests?
Driving simulators safely analyze driving behaviors in various scenarios, without risk of property damage or driver injury.
Driving simulation trials capture driving behaviors such as driving speed, acceleration, vehicle position, and lateral deviation, and gather physiological data, including electroencephalogram (EEG), electrocardiogram (ECG), electromyogram (EMG), and facial thermal imaging to study driving behaviors. Eye-tracking devices capture features such as gaze duration and frequency of gaze shifts, enabling analysis of drivers’ visual behavior and driving performance both after dosing and the following morning.
How quickly can Altasciences initiate a driving simulation study for my drug?
We have started a trial in as little as four weeks. Our driving simulators are on-site, installed in dedicated suites, eliminating shipping, installation, and calibration time.
How many CRC driving simulators does Altasciences have on-site?
We have 12 simulators permanently installed at our Montréal clinic, with space for up to 13 more. This allows us to run a variety of study sizes, small or large. Our regulatory experts can help direct you.