Back to Journals » Drug Design, Development and Therapy » Volume 11

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

Authors Lee H, Lee H, Baik J, Kim HJ, Kim R

Received 5 July 2017

Accepted for publication 18 September 2017

Published 19 October 2017 Volume 2017:11 Pages 3035—3043


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Editor who approved publication: Dr Qiongyu Guo

Howard Lee,1,2,* Heechan Lee,1,2,* Jungmi Baik,3 Hyunjung Kim,3 Rachel Kim4

1Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, 2Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, 3Clinical Trials Center, Seoul National University Hospital, Seoul, Republic of Korea, 4Global Clinical Trial Execution, Pfizer Korea, Seoul, Republic of Korea

*These authors contributed equally to this work

Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.

Keywords: clinical trial, failure modes and effects analysis, quality improvement, quality management, quality risks

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]