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Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.
Art Sedrakyan1, Danica Marinac-Dabic2, Bruce Campbell3
1Department of Population Health Sciences; Medical Devices Epidemiology Network (MDEpiNet) Coordinating Center, Weill Cornell Medical College, New York, New York, USA.
BMJ Surgery, Interventions, & Health Technologies
|November 17, 2022
Summary
A new maturity framework helps assess coordinated registry networks (CRNs) and registries for reliable real-world evidence (RWE) generation. This framework guides development and funding prioritization for health technology evaluation.
Area of Science:
- Health Technology Assessment
- Real-World Evidence (RWE) Generation
- Data Science in Healthcare
Background:
- Real-world evidence (RWE) is crucial for evaluating health technologies, supported by regulators, assessors, clinicians, and manufacturers.
- Coordinated registry networks (CRNs), especially when linked with electronic health records and administrative databases, enhance RWE generation.
- Existing frameworks for CRN and registry maturity require development to guide their optimization.
Purpose of the Study:
- To develop a comprehensive maturity framework for coordinated registry networks (CRNs) and registries.
- To guide the development and funding prioritization of CRNs and registries for robust RWE generation.
- To establish a standardized approach for assessing the maturity of RWE-generating infrastructure.
Main Methods:
- A Delphi survey was conducted with 52 diverse stakeholders, including patient advocates, academics, clinicians, and industry and regulatory experts.
- 42 experts participated in two survey rounds (July-August 2020 and October-November 2020) to provide feedback on the proposed maturity framework.
- An expert panel refined the framework based on survey responses, achieving an 80% consensus target.
Main Results:
- Consensus was reached on a maturity framework comprising seven domains: unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes.
- Each domain includes five distinct levels of maturity.
- Expert consensus estimates for the seven domains ranged from 80.5% to 92.7%.
Conclusions:
- A robust framework has been developed to assess the maturity of CRNs and registries for reliable RWE generation.
- The framework promotes harmonization of RWE generation approaches across various disciplines and healthcare systems.
- The framework's domains and levels are adaptable and may evolve with emerging solutions.
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