Christopher Kratchovil, MD, discussing clinical research with the NBU

17 May 2022

Chris Kratchovil: But, you know, very early on it was very collaborative, very controlled, very data-driven, and so we were kind of assessing, should we bring this patient in? And so I was one of the members of the leaders that got together with Chancellor Gold in his conference room and we basically went through what was the situation, the assessment, and what were the recommendations of all the folks sitting around the table, and he literally went around the table and had each person vote. “Do you think we should accept this person?” Everyone said yes, and then we went to work with what that would look like. My role was working with pharmaceutical companies that had products, some of which had only been used in animals, or very little human data, working with the FDA on getting an emergency investigational new drug approval, bringing in the Institutional Review Board because they had to quickly meet and then review the protocols and the consent forms which were being created at that time. So again, you can see this team-based approach that everyone came in rolled up their hands and needed to do and so while the biocontainment unit team was doing their thing, the clinical research teams and infrastructure and regulatory and contracts were doing their thing simultaneously, literally around the clock, while the patient was being prepared and then being flown from West Africa.

From the McGoogan Health Sciences Library Special Collections and Archives