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International Clinical Trials

Brain Power

Is a clinical trial without computerised cognitive testing brainless? Mark Cusack of CDR presents a system that can add value to trial programmes

Technological development presents a vast array of inviting possibilities for using automated cognitive testing within clinical trials. Promising quick, clean, empirical data at minimal inconvenience to the investigator and subject alike, automated cognitive testing also provides greater operational efficiencies and scientific insight.

This article aims to raise awareness of the possibilities of computerised cognitive testing by referring to first principles and establishing that when the technology is serving the science, real value and insight can be added to virtually any clinical trial programme. Specifically, why use automated cognitive testing? What are the reasons and where are the advantages? How do these relate to the different phases of clinical development? Can they generate early indications of efficacy? The author hopes to challenge current paradigms raising the prospect of scope and value that can be added by employing these systems beyond what would traditionally be considered as cognitive testing’s therapeutic footprint, and reflect briefly on what the regulatory authorities require.

WHY AUTOMATE COGNITIVE TESTING IN TRIALS

Numerous tests have shown that automated cognitive testing, in the right hands, can be superior to traditional paper and pen (P&P) measures such as the ADAS-cog, the digit symbol substitution test (DSST) and the mini mental state exam (MMSE). The test battery employed would need certain key elements such as: sensitivity in differentiating effects versus the traditional P&P tests; greater sensitivity than self ratings; being closely related to P&P measures; and have superior psychometric properties for certain conditions for example, Alzheimer’s disease. It would need to be objective as it is inherent within automated testing.


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Mark Cusack is Head of Business Development (Europe and Asia) at Cognitive Drug Research. Mark graduated with a BSc (Hons) in Business Economics with Computing from the University of Surrey. He started his career in the futures market in the City of London, after which he worked in business development and marketing roles in both the FMCG and internet sectors, latterly in marketing for Coca-Cola. Mark moved into the life sciences industry, working in late-phase business development for a full service global CRO, and is now Head of Business Development (Europe and Asia) for Cognitive Drug Research
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