Patients and their families play one of the most important roles in clinical research. Without participants, clinical research professionals would be unable to accomplish the medical advancements that improve public health. Efforts such as Clinical Trials Day, celebrated in May, acknowledge the unique stories of clinical research participants, professionals, and their families.
Olivia Sutton, a freshman at Cedar Ridge High School in Hillsborough, NC, along with her mom, Sonya Sutton, shared her first clinical trial experience, along with her thoughts on why participating in clinical research is important and impactful.
“It all started in 2018. We all had a cold, but Olivia kept coughing for months afterwards,” Sonya said. “So, we took her to the doctor and they performed several tests, including chest x-rays, to determine what the issue may be.”
Not long after, Olivia was diagnosed with exercise-induced asthma, a form of asthma caused by prolonged or extensive physical activity.
Olivia, the one-woman piccolo pro in her school’s marching band, said that her asthma began to present challenges when it came to daily life. These challenges became most noticeable in activities such as playing music or in gym class.
“I noticed I would have to take more breaths in between notes compared to my peers, or need a few extra minutes to catch my breath.” Olivia said. “It’s not that asthma stops me from doing things, but sometimes it makes things harder.”
Sonya also expressed her concerns as a parent.
“It can be frustrating because it’s impacting her life,” she said. “Asthma is one of those things that’s really hard to control, and involves a lot of trial and error. What works best for one, may not work best or the same for someone else.”
It wasn’t until Summer of 2022, however, when the two first learned about an opportunity that could help. Olivia was offered to join the GenARA study by her pulmonologist.
With the use of genotype-tailored dosing of antacids, like Prevacid, the GenARA study aims to improve asthma control and reduce symptoms associated with gastroesophageal reflux disease (GERD) in kids. Antacids are common, over-the-counter (OTC) medications often used to treat heartburn, indigestion, difficulty swallowing, and cough.
“My first thought was ‘This is interesting!’” Olivia said. “I liked that the trial was trying to see how a commonly used medicine could be used to serve a new purpose.”
Sonya added that they were interested to learn more about how to effectively combat the uncertainties of asthma. Shortly after Olivia decided to join, they received information about the study’s qualifications, followed by a phone call from the study coordinator to get started.
Olivia took part in a 6-month study period, which involved taking a liquid medication and completing brief surveys daily, performing weekly Bluetooth spirometry tests, and attending routine in-person doctor visits and virtual check ins. The study included both the intervention and a control, and the Suttons do not yet know which Olivia received.
Participants were also able to access their data via an app, which Olivia and her family found insightful.
“It was nice to have access to the data because it helped [us] track her progress throughout the study as the seasons were changing; especially since winters are tougher,” Sonya said.
Throughout the duration of the study, Olivia also earned compensation for reaching milestones and for her participation.
“It was pretty cool because my school ended up having a winter formal, so I was able to buy some new shoes for the formal with the money I earned,” Olivia said.
Along with the study’s perks, there were a few challenges. One of the biggest hurdles both Olivia and her mom agreed on were the logistics.
“Like for instance, trying to determine the best time of day for her to take the medicine consistently,” Sonya explained. “Because she had to take it with food, and our daily schedule can vary with school, work, and afterschool activities, the time she’s eating changes. One night, dinner may be at 6 p.m., the next night dinner is at 9 p.m.”
“The medicine tasted really bad,” Olivia said with a laugh. “But, even though I didn’t like it, I felt like bad-tasting medicine was a small price to pay for all of the benefits that would come out of the trial.”
Olivia also mentioned that she and her family made a fun game out of it by trying to guess if she had the placebo or the study medication.
Sonya, a communications project manager at the Duke Clinical Research Institute (DCRI), shed light on her perspective of her daughter’s experience as someone who’s well acquainted with the world of clinical research.
“Both Olivia’s dad and I work in clinical research so it was interesting to see the other side of the trial from the participant’s perspective, and how what we do contributes to the overall process,” she said, adding that they found the study materials and informed consent form extremely useful – the same materials she helps to create every day.
“I loved how Olivia took ownership and was willing to give back,” said Erin Frost, a clinical research coordinator at Duke’s Office of Clinical Research who worked on the GenARA study with Olivia and Sonya. She shared how working with families has been very rewarding and expressed her gratitude for their commitment and participation.
Erin also dove into her personal journey in clinical research when her oldest daughter participated in a study for an FDA-approved medication that helps treat seizures.
“I know what it’s like to be the parent. Ever since she participated in the study, her quality of life has improved tremendously,” Frost said. “It’s remembering the big picture and the why, because it comes from so deep for me…I want the patients and their families to have a good experience and feel appreciated because without them it wouldn’t happen.”
At the conclusion of the study, Olivia rated her overall experience a 10 out of 10.
“I felt safe and never felt worried. Everybody was super helpful, and I thought the experience was great,” said Olivia. When asked how she would respond if a friend were curious about joining a clinical trial, Olivia replied with, “I would say: ‘You should totally do it!’”
She added that, “It’s something simple you can participate in that will help people, help yourself, and provide important information that can be used for future research.”
Olivia also expressed her eagerness to learn the results from the GenARA study, and to participate in another clinical trial in the future.
“The biggest thing for me was that I liked the idea of being able to do something that would benefit a bunch of people,” Olivia said. “If I can do something that will help people in the process, that sounds pretty good to me.”
Learn more about the GenARA study.