Clinical trial operations with reliable use-case selection(CORUS) system for finding an efficacy of a functional food

Abstract

As public attention is growing on functional food, the number of clinical trials to find effects of functional food is also increasing. Until now, same clinical trial support system used for drug trials has been used in clinical trials on functional food, believing that their basic procedures are identical. However, clinical trials on functional food is different from clinical trials on drugs. Since their test subjects are healthy people, not someone with disease or disorder, the overall effect of functional food is much smaller than that of drugs. So in order to prove efficacy of functional food, we have to design clinical trials with much detailed parameters and may need to collect large amounts of data depending on set parameters. Such differences in clinical trials on functional food are not being considered in any of current Electronic Data Capture (EDC) systems. Our research goal is to tackle current problems of applying conventional clinical trial systems on functional food and develop a first of a kind clinical trial system on functional foods by integrating basic functions from pre-existing EDCs. For our new system development, we first developed Reliable Use-case Selection function for designing clinical trials on functional food. Secondly, we developed Unlimited Source Document Builder function to collect vast amount of clinical data. By combining above two functions, we finally developed a functional food EDC, Clinical trial operations with Reliable Use-case Selection (CORUS) system. It is the first attempt in clinical research field to develop a clinical trial system for functional food, and we believe that our research system can be a corner stone for development of clinical trials on functional food.