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Process Innovation Improves Trial Operation Efficiency.

Yun Jung Choi1, Kyu-Pyo Kim1,2, Sumi Park1

  • 11 Asan Medical Center, Clinical Trial Center, Seoul, Korea.

Therapeutic Innovation & Regulatory Science
|September 19, 2018
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Summary

Clinical trial operational efficiency was improved by implementing new initiatives. These changes significantly reduced delays in institutional review board (IRB) approval and subject enrollment timelines.

Keywords:
clinical trial activationclinical trial operationclinical trial timelinepreliminary reviewproject manager

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Area of Science:

  • Clinical research operations
  • Medical informatics
  • Health services research

Background:

  • Clinical trial delays can significantly undermine research investment and outcomes.
  • There is a need for systematic approaches to address and reform operational inefficiencies in clinical trials.
  • This study assesses the impact of implemented initiatives on clinical trial operational efficiency.

Purpose of the Study:

  • To evaluate the effectiveness of a composite set of initiatives aimed at improving clinical trial operational efficiency.
  • To quantify the reduction in key trial timelines following the implementation of these reforms.

Main Methods:

  • A high-volume academic medical center implemented protocol preliminary review, parallel IRB and clinical trial agreement review, and project manager involvement.
  • Key performance indicators measured included time from IRB submission to approval, IRB submission to trial open, and trial open to first patient-in.
  • A comparative analysis was conducted between pre- and post-initiative implementation periods.

Main Results:

  • Median time for IRB approval decreased from 19 to 14 days (P < .001).
  • Median time from IRB submission to trial open for subject enrollment reduced from 25 to 18 days (P < .001).
  • Median time from trial open to first patient-in decreased from 111.5 to 100 days (P = .014).

Conclusions:

  • The implemented initiatives effectively reformed and improved clinical trial operational efficiency.
  • Further research is recommended to identify and address other operational delays and factors affecting subject enrollment.
  • Continuous improvement strategies are essential for optimizing clinical trial processes.