| 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. |
