Clinical trial data solutions company ERT has tapped Cogstate, a neuroscience technology company, to expand the capabilities of ERT’s electronic clinical outcome assessment (eCOA) tool. The goal is to enhance the eCOA solution with digital cognitive endpoint measurement to improve the safety and efficacy assessment in clinical trials, including capabilities for at-home testing.
Cognition is a combination of various brain processes, such as learning, attention, memory, language, reasoning, and decision making. According to ERT, conventional assessments of cognitive endpoints are vulnerable to complexities, variability, and error, making them likely to yield unreliable and inconclusive results.
By incorporating Cogstate’s digital brain health assessments into ERT’s eCOA platform, trial sponsors reportedly will be able overcome these issues. The desired result is the ability to capture higher-quality data to support the development of treatments for CNS and other disorders.
Jim Mahon, vice president and chief strategy/marketing officer for ERT, said advanced digital technologies can improve such assessments.
“Pharmaceutical researchers and regulators are increasingly focused on understanding the impact new treatments have on the brain, so now more than ever there is a need to use digital technologies to make cognitive assessments more rapid, reliable, accessible and actionable,” he said. “By leveraging Cogstate’s digital CNS assessment through ERT’s eCOA platform, sponsors can dramatically streamline the measurement of CNS clinical outcomes, increase the quality of data, reduce patient and site burden by eliminating the need for duplicate hardware, log-ins and support desks, and gain the flexibility of remote administration for virtual visits.”
The Cogstate system includes automated neurocognitive tests with integrated analytics for understanding drug-effects related to areas of brain function such as attention, processing speed, motor function, executive function, and multiple aspects of memory.
The digital assessments are delivered in the same eCOA application and visit workflow as ERT’s patient reported, clinician reported, or observer reported outcome assessments, reportedly overcoming the limitations of manual cognitive assessments and providing speed, efficiency, and data quality benefits for clinical trial sponsors.