Alumni and students on the front lines of COVID clinical research

I began working here in August for my internship – so for the past nine months, I’ve been doing full-time school and work at the same time. We’ve been working on the Moderna vaccine trials, which began around the time I started working here. The work I do with the clinical trials involves assisting wherever I'm needed around the site. I take blood pressure readings and temperature measurements, teach participants how to use the tools we send them home with, complete data entry and answer data queries, pay and schedule the participants, and perform follow-up phone calls to check in on the patients.

Even though some of these vaccines have been approved for use, our studies are still happening. That’s a little confusing for some people – they don’t realize that these studies still go on after approval. But we only have about six months of data on the Phase 3 studies and only about a year on the Phase 2 studies. We don’t know the lasting effects of any of these vaccines, so we’re working to get more information and data on them.

The UNCW program lays a lot of the basic groundwork for what we do in clinical trials. But even though I know the duties of a research assistant, doing it in person is a lot different, and it’s been a good experience to work with patients. They get so excited about participating, whether it’s in the COVID vaccine studies or others we have going on. People are excited to be part of something bigger than themselves. And it’s crazy to think about how, in the big picture, I’ve been a part of something that’s affecting so many people.

I started working at PMG on May 7, 2018 – the first business day after graduation. I was hired as an assistant, and now I’m the lead coordinator on the Regeneron monoclonal antibody COVID treatment trial (this is the same drug that was given to President Donald Trump last fall). Here, we’ve worked with COVID-positive patients. I helped with the recruitment of patients and conducting the blinded portion of the visits. My study, specifically, has been enrolling our patients since August 2020, and we will enroll our 450th patient this week (in early March). But the work on our end is nowhere near done.

Clinical research is an incredible industry. Even before COVID, I felt an incredible sense of pride in the work we do. During the COVID treatment trial, my team and I have had patients return to the site after their study participation is completed with gifts and cards, many of them claiming wholeheartedly that the treatment saved their life. Everyone at our site has been working tirelessly since August – no weeks have been under 60 hours and most have been 70ish. But none of us would trade a second of it for anything. We are motivated by making a difference and advancing healthcare to a safer and more efficient level. All companies in clinical research take the time to train their employees, and they do it well. But having a clinical research degree – particularly one from UNCW – puts you miles ahead of other peers. You can tell by how quickly someone understands the terminology and their understanding of the entire process of clinical research that they went through the program at UNCW.

I typically work at our satellite sites where doctors want to work with Accellacare on research. But when I can, I work at our core site helping with the Novovax and Pfizer vaccine trials. We have people helping with electronic data capture, helping the patients be seen and helping make sure that patients are scheduled in the right time frame. There are clinical research coordinators and doctors and patients all interacting in the trials together. When you have this many patients, it has to be a group effort.

We started the trials late last year with just the Pfizer vaccine, and now we’re working with multiple vaccines and studies. We’re doing a Pfizer lot study, comparing whether the vaccine manufactured in one city is the same as one manufactured in another city. We’re testing a lower dose of the vaccine for younger patients. And a study coming soon will test whether the Pfizer vaccine can be refrigerated instead of being dependent on that crazy low temperature requirement.

Before COVID happened, people really had no idea what clinical research was. Now, there’s a feeling of appreciation from the community we haven’t had before. To be on the front lines and helping people, and seeing firsthand all of the volunteers participating in these trials – most of them left the room thanking us for doing this when they’re the ones who should be thanked. It’s been overwhelming and really incredible.

My current role focuses on operations – it’s been a lot of hiring and making sure we have the capacity to run these studies and take on this high volume of patients. For the Regeneron studies, people at first were a little hesitant. It was a bit scary to think we were going to be exposed to COVID-positive patients. That was a barrier we had to overcome. Now, we’ve put in more than 500 patients for this trial in Wilmington alone and we’re nearing our enrollment goal. It’s also been a lot of figuring out logistics, working to ensure we have proper PPE for our staff, and thinking through how we can run this study so we can offer something amazing to the community.

Inclusion has been really important to our vaccine trials – the manufacturers want diversity so they can see how the vaccine impacts everyone. Word of mouth has been really helpful. Having some of our patients go back to their community groups and say, “Hey, I participated in this, are you interested?” is much more effective than running a TV ad. We’ve also been trying to get out (safely) into the community to meet with people, educating on our need for their help, and that’s helped us get the diversity we needed in these studies. This process has exposed a lot of people to the kind of work we do and what we can contribute.

It’s funny, my friends and family used to ask, “What exactly is it that you used to do again?” Now, you have family that are calling and saying “I’m so excited you’re part of this.” A lot more conversations are happening – they’re finally interested in clinical research and seeing the impact it has on the community, their family, and themselves.