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Bridging the Patient-Center Outcome Research Infrastructure and Technology

Publication Date
Food and Drug Administration/ORISE Fellows: Danica Marinac-Dabic, Marti Velezis, Laura Gressler, Ruston Koonce, Alex Liebeskind, Andrea Iorga, Andrej Radoja, Marco Minai, Marta Steliac
Weill Cornell Medicine: Art Sedrakyan, Suvekshya Aryal, Jialin Mao

The goal of this project was to strengthen the coordinated registry network as a real-world data source for high quality, relevant, reliable, timely and actionable evidence to improve patient outcomes of medical devices, specifically for technologies affecting women’s health. This was done by advancing their ability to capture standardized data, include patient generated data, and link their registry data to additional data sources.

Two examples of major accomplishments and products are:

  • Through engagement of key stakeholders, FDA developed an innovative maturity framework for registries/CRNs using important aspects of infrastructure building in seven critical domains: unique device identification, patient engagement and patient reported outcomes (PRO), data quality, efficiency, governance, sustainability, and fitness for use during the total product life cycle. Mature CRNs as well as early CRNs participated in the assessment and found it beneficial to systematically evaluate their data infrastructure.

The framework is described in the recently published manuscript in BMJ-SIT

[1] Food and Drug Administration: Center for Devices and Radiological Health. Evaluation of Sex-Specific Data in Medical Device Clinical Studies. Published online 2014:1-26.

[2] U.S. Food and Drug Administration Center for Devices and Radiological Health. The CDRH Health of Women Strategic Plan.

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