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  5. Michael Ngyuen, M.D. - Transcript
  1. Regulatory Science in Action

Michael Ngyuen, M.D. - Transcript

How FDA efficiently monitors the safety of medical products on a massive scale

Dr. Ngyuen What’s beautiful about epidemiology is that whereas in clinical practice you see patients one at a time. With epidemiology you can take, you can really focus on a single issue, study it thoroughly across thousands of patients and come to a conclusion that is novel, or was not known before.

Text Slide:

Michael Ngyuen, M.D.

CDR

US Public Health Service and FDA Sentinel Program Lead

Office of Surveillance and Epidemiology

Regulatory Science Staff

Dr. Ngyuen: Sentinel is an active surveillance program created by the Food and Drug Administration used to monitor medical product safety of its vaccines, drugs, biologics, and devices

Traditionally FDA has relied on passive surveillance. We rely on patients or doctors to notice adverse events and report them to the FDA.

One of the signature achievements of the Sentinel system is the distributed database. This is really the mechanism that enables 17 data partners, health maintenance organizations, national health insurers, be willing to share their data with the FDA.

And they contribute data on more than 200 million Americans. That allows us to do analysis that previously took, one, two, three years to do, and now we can do in a matter of months.

All the analyses stay behind a firewall, protected, and private, and the data always reside in the control of the original data holder. The only thing that gets sent back to the FDA and the coordinating center are aggregated data, stripped of protected health information, and results.

We’re able to see every time that a patient receives a medication, or receives a vaccine, or receives some other therapy or device. And we’re able to look forward in time and see, what kind of reactions did they have, at the same time we’re able to look backward in time and assess any underlying patient risks to them and control for those patient risks.

So one great example was a study recently done on the safety of two vaccines to prevent rotavirus infection, rotavirus is the leading cause of infant diarrheal illness. Prior versions of the vaccine were associated with elevated rates of intussusception, which is a form of bowel obstruction in infants, and we analyzed the data on more than a million infants, for these two vaccines, we found that the rate of intussusception was substantially lower than prior vaccines. And so the benefits far outweighed the risks.

Sentinel has enormous potential, with all of its data partnerships, the massive scale at which we can do analyses now, in ways that are much faster and much more efficient than previously. We’re looking forward to the future.

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