Cogstate test to be used in paediatric clinical trial

Cognitive assessment and training company Cogstate has announced that its technology will be used in a large paediatric clinical trial in the United States.

In recent years there has been a shift in the way children are treated in clinical trials, with an enhanced focus on safety and efficacy as it relates to their physical and cognitive development. Safety is a difficult concept in children, because risks to physical or cognitive development may not be seen for months or years afterwards.

Cogstate conducts high-quality, cost-effective testing of drugs with the potential to affect children’s cognition and neuropsychology. Under the new contract, worth approximately US$1.4 million over four years, the company will measure any changes to cognition as an endpoint measure of safety.

“Our brief, game-like tests are well accepted by even the sickest children - for example, in an earlier study we found more than 98% of children with acute lymphoblastic leukemia were able to complete them,” said Brad O’Connor, Cogstate CEO. “Previous methods using onerous paper and pencil tests yielded far lower adherence rates in sick children, resulting in missed opportunities to compare the risks and benefits of various treatments.”

O’Connor said the clinical sponsor of the trial was being encouraged by regulators to include such tests, but was concerned about the ability of sick children to complete them. “When the sponsor learned of our work in this area,” said O’Connor, “they engaged us to find a solution that the children could easily complete, but which would still deliver the highest quality data.”

This is the second paediatric contract signed by the company in the last seven months. Furthermore, it follows the award of US$1.2m in other contracts in the clinical trials business already signed since 1 January 2014.