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Registry-based trials: a potential model for cost savings?
Brett R Anderson1, Evelyn G Gotlieb2, Kevin Hill3
1Division of Pediatric Cardiology, NewYork-Presbyterian/Morgan Stanley Children's Hospital, Columbia University Irving Medical Center, New York, NY, USA.
Cardiology in the Young
|July 2, 2020
Summary
Registry-based trials significantly reduce clinical trial costs compared to standard trials. A new tool helps estimate these savings, which depend on patient numbers and data elements, making research more cost-effective.
Area of Science:
- Clinical Trial Design
- Health Economics
- Data Management
Background:
- Registry-based trials offer potential cost savings.
- Previous estimates conflated registry benefits with pragmatic trial designs.
- A need exists for a tool to estimate cost differences.
Purpose of the Study:
- Develop a practical tool for estimating cost differences between registry-based and standard clinical trials.
- Provide investigators across disciplines with a method for assessing potential cost savings.
Main Methods:
- Utilized simulation Markov models to compare data acquisition, cleaning, and linkage costs.
- Performed sensitivity analyses (one-way, two-way, probabilistic) on study characteristics.
- Identified thresholds for optimal selection of trial designs.
Main Results:
- Registry-based trials were more cost-effective in 98.6% of simulations.
- Data-related cost savings ranged from $4,300 to $600,000.
- Savings were sensitive to patient numbers, data elements per patient, and manual data abstraction speed.
Conclusions:
- Registries are valuable resources for reducing clinical investigation costs.
- Broad incorporation of registries can benefit the scientific community.
- A practical tool is provided for assessing potential cost savings.
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