Streamlining patient selection for clinical trials, improving efficiency and enabling better use of real-world data
Fujitsu Limited and Tokai National Higher Education and Research System (THERS) today announced the successful completion of field trials using generative AI to process clinical data for use in the selection of clinical trial participants. The effort aims to address the issue ‘drug loss’ in Japan, i.e., a lack of availability of drugs used overseas due to stringent local approval requirements.
In a clinical setting patient data can be broadly seperated into structured data, i.e., organized and quantifiable data such as vital signs and lab results, and unstructured data, i.e., data that lacks a predefined format such as doctors’ notes. Structuring unstructured clinical data has traditionally been a time-consuming manual process. These field trials used data from approximately 1,800 patient records of breast surgery procedures obtained from Nagoya University and Gifu University. Unstructured data was successfully structured at approximately 90% accuracy. Leveraging this newly structured data, a screening of three clinical trial projects identified 42 potential candidates, 27 of whom were actually eligible, potentially reducing patient selection time by approximately one-third. This enables faster decision-making and increases patient access to optimal clinical trials. Moving forward, both organizations will work to expand the number of target diseases and participating facilities, and improve the accuracy of this approach, while promoting its use in actual clinical trials.
Fujitsu and THERS will further link the results of these field trials with Paradigm Health, Inc.’s state-of-the-art clinical trial platform to accelerate the use of real-world data (RWD). This will enable collaboration with medical institutions and pharmaceutical companies to enhance the planning and overall execution of clinical trials, and help mitigate drug loss in Japan.
Future Plans
THERS aims to actively attract international joint clinical trials to the Japanese Tokai region and improve patients medical care by increasing operational efficiency and utilizing a clinical research environment for handling high-quality clinical data.
On May 30, based on the results of these field trials, Fujitsu will expand its Healthy Living Platform and launch a function to promote the structuring and utilization of medical data using its AI service Fujitsu Kozuchi. This function will also be linked with the enterprise large language model (LLM) Takane in the future to support the advancement of data analysis in clinical research and the efficiency of patient selection.
Fujitsu will continue to contribute to improving the overall performance of clinical research and the development of medical care in Japan under Fujitsu Uvance, its business model oriented around solving societal issues.
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