Clinical Data Management in Japan: Past, Present, and the Future

Inthe past 10 years in Japan, clinical trial design and analysis have improved owingto the increased understanding of the role ofresearchers inclinical trials and acknowledging thecontribution of biostatisticians. However, during this time, studies havemainly focused on clinical data management (CDM) and the technicalaspects of trials (e.g., data collection and entry, check), and many differences existamong sites. For clinical trials within academia, although the introduction ofElectronic Data Capture (EDC) had begun, data collection using paper casereport forms was still the mainstream. The aimof CDM was to ensure maintainingthe quality of data at an appropriate level to allow for fair scientificevaluation, and this was not recognized in many educational activities. Therewas an impression that the role of CDM was underestimated because it was notsufficiently positioned as a “profession” in conducting clinical trials. Tosummarize, 1) there was little awareness on the importance of CDM, 2) theeducation system for CDM was not in place, and 3) systematic CDM research wasconducted. Today, with the widespread use of electronic technologies, such asEDC and electronic Patient Reported Outcome, and the introduction of qualitymanagement and risk-based approach, data managers have more opportunities toaccess real-time data. As such, the work ofdata managers has diversified and the range of roles has expanded. Recently, we aimed to establish the Society of Clinical Data Management (SCDM)Japanese Branch to 1) disseminate the activities of SCDM inJapan, 2) promote the value of certified clinical data manager (CCDM) amongJapanese CDM, 3) strengthen the CDMnetwork through the SCDM Japanese regional office, and 4) provide acomprehensive educational program on CDM through SCDM educational material suchas Good Clinical Data Management Practice (GCDMP) to CDM in Japan. SCDM Japan wasofficially approved in February 2019 and the Japanese page of the SCDM website (https://scdm.org/japan/) wasfunctional in August 2020. Sixteen steering committee members from academia,industry, and regulatory affairs manage SCDM Japan. We have five sub-committees,namely, GCDMP, Certification (CCDM), Membership, Publication, Education, andOnline Course Committee. Activities are introduced on the SCDM Japan website. In this specialarticle, we summarize the brief history of CDMin Japan. Here, we have presented special circumstances in which pharmaceuticalcompanies, and not academia, have laid the foundation for clinical trials. We haveexplained the differences in the role of clinical datamanagers in academic research organizations, pharmaceutical companies, and Contact research organizations. The currentstatus and issues of CDM in Japan are introduced, including training, education,and career paths for CDM professionals. Lastly, we express our expectations forthe future of CDM in Japan.