Medical technology company Cogstate Limited (ASX:CGS) has today announced its technology will be used in a large paediatric clinical trial in the United States.
Under the contract worth approximately US$1.4 million over four years, the Cogstate Test will be used to measure any changes to cognition as an endpoint measure of safety.
This latest contract consolidates the Company's growing foothold in the paediatric clinical trials market. This is the second paediatric contract signed in the last seven months with a combined value of approximately US$3 million. Four contracts have been signed over the last few years for the Cogstate Test to be used as an endpoint in paediatric safety studies.
"Our central involvement in paediatric safety studies is a new exciting growth area in our clinical trials business and suggests a growing awareness of, and appreciation for, Cogstate's paediatric tools for their sensitivity, reliability and comparatively low subject burden, a huge advantage in studies of ill children," said Mr Brad O'Connor, Cogstate Chief Executive Officer.
In recent years there has been a fundamental 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. In children, safety is a difficult concept, because risks to physical or cognitive development may not be seen for months or years afterwards.
Cogstate is uniquely placed to conduct high quality, cost-effective testing of drugs with the potential to affect children's cognition and neuropsychology. The ease of completing a test is a major advantage.
"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. 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."
"With normative data for over 40,000 children, many of whom have been tested annually, Cogstate offers a unique benchmark for tracking normal cognitive development," Mr O'Connor said.
The trial was initiated at the request of the clinical sponsor.
"Regulators were encouraging the sponsor to include an onerous battery of paper and pencil tests in the trial; understandably, they were concerned about the ability of sick children to complete these."
"When the sponsor learned of our work in this area, they engaged us to find a solution that the children could easily complete, but which would still deliver the highest quality data. Cogstate was able to provide robust scientific support for the validity of the tests, and this was accepted by both sponsor and the regulator," Mr O'Connor said.
