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FDA POST-MARKET SURVEILLANCE PROJECT

The Food and Drug Administration (FDA) is in discussions with NPA to establish a

collaborative registry project that would provide post-market surveillance services

to the FDA and industry. The Medical Device Epidemiology Network (MDEpiNET) is a

national planning board tasked with evaluating regulatory-grade data sources for the

establishment of a national, and possibly international, coordinated registry network for

medical device studies to identify complications. Established registries, such as those

developed by NPA, provide the potential to enhance post-market device evaluation in a

cost-effective and standardized manner.

NIH OPPORTUNITIES

The National Institutes of Health (NIH) is discussing a potential registry project to

generate data for un-ruptured intracranial aneurysms through a multi-center registry,

with propensity matching. Other potential projects include studies on brain metastases.

WHAT WE HAVE LEARNED

The NPA focuses its clinical registries on promoting the quality of surgical care and

providing surgeons with the means to assess risk-adjusted measures of the value and

durability of treatment responses. Its registry programs and collaborative efforts assist in

the understanding of patient perspectives on clinical outcomes and provide the ability to

compare the relative effectiveness of various therapeutic interventions.

Clinical data registries have become valuable tools to support evidence development,

performance assessment, comparative effectiveness studies and adoption of new

treatments into routine clinical practice. The NPA remains committed to its efforts to

provide surgeons with the means to demonstrate value and validity in reporting and

improving quality of surgical care through the collection and analysis of outcomes data.