POST MARKET SURVEILLANCE
Ensuring Diagnostics Perform Safely and Fairly in Real-World Use
The Challenge
Approval of a diagnostic test is only the beginning. Once in use, a diagnostic test must continue to perform accurately, consistently, and equitably. However, there is current guidance is high level guidance with few practical details on how best to design post-market surveillance for diagnostics.
Our Focus
WP2 advances methods in PMS design to improve practical detailed methods to monitor diagnostic tests throughout their lifetime.
We will:
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Advance statistical approaches for diagnostic post-market surveillance
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Provide examples of methods to detect changes in diagnostic performance
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Explore opportunities for using real-world data in PMS
Why It Matters
For diagnostics, monitoring ongoing clinical performance is important to detect risk of missed diagnoses, incorrect results, and unequal performance across populations. Without strong surveillance methods, these risks can go unnoticed.
What Success Looks Like
Advancing better designs for PMS studies, through advancing statistical methods and improving the accessibility of methods. Better practice in PMS would allow regulators, manufacturers, and health systems to detect problems early and ensure diagnostics remain reliable, safe and fair in everyday practice.