Drug Evaluation Committee Central Monitoring Survey on the Current Status of Risk Indicators and Fraud Detection
December 2020
ICH E6 (R2) reached Step 5 in Japan on July 5, 2019, and guidance documents were issued by the Pharmaceutical Evaluation and Management Division of the Bureau of Health and Welfare, Ministry of Health, Labor and Welfare, completing its incorporation into domestic regulations.Consequently, it has been explicitly stipulated that it is the sponsor’s responsibility to implement a Quality Management System (QMS) for clinical trials and research.Consequently, this report presents the results of a survey—conducted via questionnaires to member companies of the JPMA Data Science Subcommittee and a literature review of published papers—aimed at assessing the current status of central monitoring methods for clinical trial risk surveillance and fraud detection methods for monitoring research misconduct.Based on these results, we present detailed implementation examples—including risk indicators, their thresholds, and fraud detection—along with each company’s current implementation status and published literature.
Furthermore, in recent years, analysis software vendors have developed various systems that enable the monitoring of clinical trial progress and risk control status for the implementation of RBM.Furthermore, based on these systems, monitoring CROs are increasingly offering comprehensive contract services to support the implementation of RBM. Therefore, with the cooperation of the Japan CRO Association and others, we requested information from several CROs and vendors referred to us, and we present the characteristics of the various systems and services identified through interviews with the cooperating companies.
We hope this publication will help refine the RBM practices of each company and contribute to improving quality through the implementation of clinical QMS.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee, Data Science Subcommittee
FY2019 Task Force 3: Central Monitoring