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

Howard Lee1,2, Heechan Lee1,2, Jungmi Baik3

  • 1Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital.

Drug Design, Development and Therapy
|November 2, 2017
PubMed
Summary

Failure mode and effects analysis (FMEA) significantly improved clinical trial quality by identifying and mitigating risks. This risk management tool enhanced processes at a tertiary care center, demonstrating its powerful application in research settings.

Keywords:
clinical trialfailure modes and effects analysisquality improvementquality managementquality risks

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Area of Science:

  • Clinical Research
  • Quality Improvement
  • Risk Management

Background:

  • Failure Mode and Effects Analysis (FMEA) is a proactive risk management strategy.
  • FMEA aims to identify and assess potential system failures and their causes/effects.
  • This study evaluated FMEA's effectiveness in an academic clinical trial center.

Purpose of the Study:

  • To assess the impact and effectiveness of FMEA implementation.
  • To identify and mitigate risks within core clinical trial processes.
  • To improve overall quality in clinical trial operations.

Main Methods:

  • A multidisciplinary team applied FMEA to 6 core clinical trial processes.
  • Potential failure modes were identified, and Risk Priority Numbers (RPNs) were calculated.
  • Remedial actions were developed for high-risk failures (RPN >160), followed by a one-year reassessment.

Main Results:

  • 114 failure modes were identified, with RPNs ranging from 3 to 378.
  • Fourteen high-risk failure modes were identified; 11 were addressed through interventions.
  • Re-scoring demonstrated significant quality improvement, with occurrence and detection scores reduced.

Conclusions:

  • FMEA is a potent tool for enhancing quality in clinical trials.
  • The Seoul National University Hospital Clinical Trials Center is expanding FMEA use.
  • Implementing FMEA leads to measurable improvements in clinical trial processes.