Clinical Trial Participation:
A Family Affair
When the COVID-19 pandemic first began, Theresa “Terry” Bauer-Brown was a middle school counselor residing in Charlotte, NC, with her husband, Frank. She was also the primary caregiver to two elderly parents. “Everyone was struggling,” she recalls. “I knew I needed to do everything in my power to protect myself and those I serve, both family and students alike. There was only one problem. I didn’t know what to do.”
That was before Terry received an email from her primary care physician highlighting the opportunity to participate in a COVID-19 vaccine clinical trial at Tryon Medical Partners, in Charlotte. “At the time, I didn’t really think about how enrolling would protect me, and in turn my parents or students,” said Terry. “My primary motivation for participating was rooted in the realization that I could do something – anything at all.” As a relatively healthy individual herself, she then turned to Frank; “we decided to try. It just seemed like such a great fit.”
After expressing their initial interest, the couple was able to visit the clinic and began asking questions, lots of them. “We had friends who lost children; so many people were sick and struggling,” said Terry. “I was very concerned. When I began to understand the immense impact that this clinical trial could have on public health and in turn my family and friends, students, and myself, enrolling was a no-brainer.”
In a blinded study, participants are unaware of whether they receive the placebo or the actual investigational vaccine, as was the case for Terry. The trial included clinic visits to complete blood draws and shots, as well as continuous symptom tracking at home. The informed consent process – as with most studies – was lengthy, and intricate. The risks were clearly outlined, along with the benefits. For extra peace of mind, Terry consulted her brother, a professional in the medical field. “There are risks,” he emphasized, acknowledging the realities of innovative drug development, “but you are a perfect fit for this.”
“Looking back, we really had no idea what we were getting into,” Terry recalled, “but it helped that we were in it together.” Making participation a family affair, Terry and Frank were able to coordinate their clinic visits and found comfort and peace of mind in sharing the experience.
Additionally, Terry’s own PCP, who had provided information about the opportunity initially, later enrolled as a participant herself. “Having this connection absolutely contributed to my confidence in the decision to participate,” Terry explained. “It was a great support to be able to talk through the experience with a medical professional, not to mention the added value of already having a trusted relationship with that individual.”
Participation was a commitment, not only because of the symptoms experienced after some injections, but because of the continuous monitoring, blood draws, and evaluations. “There were a lot of trips to the clinic, and we live thirty minutes away,” said Terry. “It was a lot to manage; the materials, the diary, all of it. But it was so worth it.” She added that the support and understanding from the clinic staff was invaluable. “I think as a participant, it is important to remember you aren’t expected to know everything. Let the clinical trial professionals guide you – they understand far more than you likely ever will.”
Adverse reactions, or COVID itself, were of course a possibility, but having the detailed care and attention of the study team, Terry emphasized, eased those concerns. “Throughout the study, we had digital surveys, weekly calls, check-ins…when we did fall sick with COVID about a year and a half later, we were seen immediately, monitored continuously, and guided every step of the way – communication helped make it feel manageable,” she added. “I felt fully supported.”
Terry and Frank’s overall trial experience was so positive, they continued participation in the following booster study as well. And while compensation was never their primary motivation for enrolling, “it was a nice chunk of change.” At the close of the studies – having both received the vaccine as well as the booster – the couple put their unplanned financial gain toward nothing less than a trip to Kenya.
When asked what advice she might give to those considering participating in a clinical trial, Terry shared:
“If you’re a healthy person, the opportunity to be on the cutting edge of medical research and science while also supporting your own health is unparalleled. Reach out to your PCP; find out if you’re a good candidate. Ask a lot of questions. Leverage medical professionals in your network to help guide you if you are unsure. If you enroll, do everything in your power to meet the study’s expectations of you; and then reap the benefits.”
Perhaps then you might even take a trip to Kenya.
“I’m eyeing Javara all the time,” she added. “Everything was so well run. We are all in.”