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A hybrid automated event adjudication system for clinical trials
Fei Yuan1,2, Jackie Bosch1, John Eikelboom1
1Population Health Research Institute, Hamilton, ON, Canada.
Clinical Trials (London, England)
|February 3, 2023
Summary
An automated event adjudication system streamlines clinical trials by confirming outcomes, significantly reducing human review time. This hybrid approach enhances efficiency in processing critical trial data.
Area of Science:
- Clinical Trials and Regulatory Science
- Health Informatics and Data Management
Background:
- Clinical trial event adjudication relies heavily on manual review by human experts.
- Current processes face challenges in automating communication and outcome confirmation.
- There is a need for efficient systems to manage and verify clinical trial outcomes.
Purpose of the Study:
- To present an automated event adjudication system designed to improve clinical trial efficiency.
- To evaluate the system's application and impact in two major randomized controlled trials.
Main Methods:
- Developed a system that automatically assesses and classifies clinical trial outcomes based on predefined criteria.
- The system confirms or unconfirms outcomes, updating their status in the database.
- Applied the system in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) and NAVIGATE ESUS trials, using a hybrid model with human oversight for unconfirmed cases.
Main Results:
- The automated system adjudicated a significant number of outcomes in both COMPASS (3283) and NAVIGATE ESUS (737) trials.
- Confirmation rates for adjudicated outcomes were 50.3% in COMPASS and 52% in NAVIGATE ESUS.
- The system reduced human review time by approximately 45% in COMPASS and 49% in NAVIGATE ESUS.
Conclusions:
- The automated event adjudication system, combined with human adjudicators, offers a streamlined and efficient approach.
- This hybrid model effectively manages and confirms clinical trial outcomes.
- The system is recommended for immediate application in clinical trials, with human assistance for complex cases.
Keywords:
Automatic event adjudication systemData Safety Monitoring Boardclinical data management systemevent adjudicationevent adjudication committeeMore Related Videos
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