Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct

• Published in: Drug design, development and therapy Vol. 11; pp. 3035 - 3043
• Main Authors: Lee, Howard, Lee, Heechan, Baik, Jungmi, Kim, Hyunjung, Kim, Rachel Youkyung
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2017; Taylor & Francis Ltd; Dove Medical Press
• Subjects: Analysis; clinical trial; Clinical trials; Drug administration; Failure; Failure analysis; Failure mode and effects analysis; Failure modes; failure modes and effects analysis; Health risk assessment; Heart attacks; Hospitals; Human subjects; Intensive care; Medical care; Medical research; Microprocessors; Mortality; Original Research; Patient safety; Quality; Quality control; Quality improvement; Quality management; Radiation therapy; Regulatory agencies; Risk analysis; Risk assessment; Risk factors; Risk management; System failures (Engineering); South Korea; clinical trial; quality management; quality risks; quality improvement; failure modes and effects analysis
• ISSN: 1177-8881; 1177-8881
• DOI: 10.2147/DDDT.S145310

Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later. A total of 114 failure modes were identified with an RPN score ranging 3-378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively. FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes.