The Impact of Innovative Medical Information Integration System on Clinical Research in Japan

Background: Advances in information and communication technology supports many aspects of medical practices and clinical researches. Data collection using case report form (CRF) requires manual works and makes burden to researchers and cost. A system that assembles and manages data from different formats and multiple data sources into a centralized system, Clinical data management system (CDMS), has been introduced in Japan since 2014.

Objective: To describe the function of innovative database, CDMS, and feasibility of implementing and using sharable and comparable medical data for clinical research.

Design/Methods: CDMS, a user-friendly, versatile, and secure network system for data and knowledge management has been assembled in Japan. CDMS for patients was introduced to outpatient department to take patient history and interview. CDMS integrates disease, laboratory data, and prescription from multiple platforms of electronic health record in each institute and patients’ medical interview and history.

To evaluate the feasibility of CDMS for clinical research, the observational items used in CRFs of clinical trial conducted at Tokyo Metropolitan Children’s Medical Center in 2016 were sorted and the proportion of items that could theoretically be covered by CDMS was evaluated.

Results: The versatile database covered everything about pediatrics from infants to child medical records. CDMS used a metadata-driven model that contained built-in knowledge bases to control medical terminology. Among the CRFs from 4 clinical trials, patient medical interview and history, disease, prescription and laboratory data accounted for 33.0±39.4%, 0.6±0.9%, 18.6±16.7% and 21.8±12.3%, respectively. CDMS covered 73.9±41.4% of observational items in clinical research.

Conclusions: CDMS broadly covered the observational items in clinical research and was showed the usefulness for it. CDMS also functions as a platform to realize randomized registry trial and will reveal the real-world evidence in clinical care, home or community settings. CDMS will change clinical research from hypothesis testing to confirming the correlation between the big data and every medical thing.