Kira Pavlik | The Clinical Trials Imaging Accuracy Crisis Panel Discussion

Speakers: Kira Pavlik, Associate Director, Clinical Trials Operations | Yale Cancer Center

Kira Pavlik: The FDA looks at this with high levels of scrutiny. I don't know if many of you have been in FDA inspections. We had one fairly recently that went very well! But, I remember sitting in the room with that inspector for an entire week, and he had me pull up our Yunu system. He looked at every single number for every single patient, and for every single time point. We were there for a very long time. And I remember, you know, he kept saying, ok, where did this number come from? Where was the re-read, how is this documented in Epic? What was the decision thought process here? What was the delay here? Why did this happen? And I think, you know, that was a huge piece of, you know, why we didn't have findings for that respective inspection. But, they look at, especially, when you're looking at bringing this drug to market that's not just going to impact the patients that you have at your site, but patients potentially world-wide. The massive impact that could have and whether or not that drug is actually effective in patients.