In 2020, the COVID-19 pandemic forced the scientific community across the globe to mobilize at “warp speed” to evaluate potential treatments and vaccines to stem morbidity and mortality from the virus. The rapid progress required tremendous resources, collaboration, and innovation across the pharmaceutical industry and government.
Essential to evaluating potential vaccines, thousands of healthy individuals raised their hands to volunteer for participation in vaccine trials. Three Greenphire employees described in this article were among the hundreds of thousands of clinical trial volunteers participating in Covid Phase III vaccine clinical trials.
What inspired them to participate? The desire to make a difference for the health of society globally. Through their participation, meaningful insights were obtained regarding the actual experience of clinical trial participants, who we support at Greenphire with our technology solutions. Below are some of these insights:
1. Why did you volunteer to participate in this study?
Joe: I knew participants were needed by all sponsors and wanted to do my part. The study design was initially placebo (I believe 1/3 placebo participants) vs 1 vaccine shot. I therefore knew I had a 2/3 probability of maybe getting the vaccine sooner (I’m over 50 years old). I learned from the study team I received the “real vaccine” in Feb 2021 when they unblinded me in April.
Dave: I’ve worked with many clients at Greenphire to help implement ClinCard for the benefit of the site and study participants, but I hadn’t enrolled in a clinical trial myself. I volunteered to understand the experience of participants in a trial.
Erica: There were several reasons that drove my interest in participating. Working at Greenphire, I’ve been in this space for a while, but this gave me the opportunity to further understand the clinical trial process – from the lens of the most important stakeholder, the trial participant. Also, as a parent, I wanted to ensure that my family was safe and the vaccine could offer some of that protection if I got vaccinated; I trusted the science and was willing to get the vaccine within a trial ahead of it becoming widely available and approved for emergency use.
2. Have you ever participated in a clinical trial before?
Joe: Yes, as a healthy volunteer at the Medical University of South Carolina where I previously worked, I would see recruitment flyers in the elevators all the time. I’ve participated in a sleep study, a dental study/diabetes study, a hearing study, a smell study, and a study in Rheumatology where I just donated blood.
Dave and Erica: No
3. How long is the study and how many visits?
Joe: Ten visits and approximately two years.
Dave: Six visits so far and they follow for another year. In total, it’s about seven in person visits plus a few phone calls.
EC: Approximately 2 years. My first visit was in November. It was a “double visit” where they did my initial screening visit and my injection visit on the same day. I have since had 5 visits including my unblinding visit where it was revealed that I was in the active group. I will have another 2 visits later this year and continual follow-ups through out next year also.
4. What have you learned so far by participating?
Joe: I learned I get compensated via ClinCard from a small site client here in SC. I must say it’s been working great, by the time I get home from the study visit the study milestone payment is already on my CinCard. I have become familiar with the MyClinCard webpage to check my balance and transactions. I also learned how easy the IQVIA app is to record my weekly symptom checks and how helpful the study visit text reminders are I receive the day prior.
Dave: I’ve learned firsthand about the burdens some participants experience. It can be worse than you’re expecting! For example, you need to account for drive time and traffic. Most of my appointments were scheduled for 8:00 am, and I would try to be home by 10:00 am so I didn’t miss too much work. Thankfully, the location was relatively quiet and easy to find on a local university campus. It was interesting to visit the site as they typically conducted studies for HIV. Another complicating factor was that I was initially a screen fail for the study. As a result, my initial visit took longer than expected and I wasn’t sure if I was going to be able to participate in the study, but in the end, I was able to.
Erica: So many of us are in this industry, and while we hear about the challenges of participating in research, it’s yet another to experience them and see the pressures faced by trial sites. I also travelled to Philadelphia to a large academic medical center–it was bustling with people. It was a bit nerve-wracking as we were still very much in quarantine at that point, I hadn’t been around that many people in a long time (~approximately 50 people). I hadn’t even been to the grocery store! The site staff were wonderful people, with experience from clinical areas all around the hospital. While they did a great job, you could see the stress they were under to process enrollments and service all the study volunteers. My first visit was almost five hours, because of how busy they were. Thankfully, subsequent visits have been really quick, just blood draws and vital checks.
5. Do you receive travel reimbursement or compensation for your time and efforts?
Joe: Only milestone visit compensation, no travel reimbursement for gas/mileage; there is free parking at the site.
Dave: Just milestone visit compensation, no travel reimbursement. My stipends barely covered my gas and parking.
Erica: I was paid a stipend for visits and non-visit diary completion. No additional money for parking.
6. What payment method was used and was that an efficient/easy process?
Joe: ClinCard. Very easy, no issues. I’m paid the same day.
Dave: Flat stipend via ClinCard.
Erica: I received a ClinCard!
7. What technologies are being used to remind you of study visits and study-related tasks?
Joe: I downloaded the IQVIA app provided to record weekly symptom checks and I receive study visit text message reminders from the site.
Dave: Everything that I’ve done has been pen and paper.
Erica: In my study, I also use the IQVIA app to record symptoms at home.
8. Did you feel fully informed about the purpose of the study, any risks, and time and effort required for the entire study?
Joe: Yes, the Informed Consent was very detailed, about 28 pages long and the PI and study coordinator reviewed and explained everything to me over the phone initially, then in person. I was also given a useful handout that shows the timeline for all study visits and what happens at each visit (blood draw and temp check, temp check only, vaccine, unblinding date, etc).
Dave: Yes, I felt very informed. Not only did I read the protocol on my own, but the site staff went through the informed consent. The staff walked through study timelines, responsibilities and more. The IC was about 10-12 pages and it was written in easy to understand language.
Erica: I did feel very informed, but that didn’t mean that I wasn’t nervous about participating. However, the nerves were outweighed by the benefit of participation. Another thing that made me feel more comforted was that nearly everyone at the research site was also participating in the study. I thought to myself, “if all these medical professionals are also doing it, I’ll be fine.”
9. Any advice to others who may wish to volunteer a healthy control for a clinical trial?
Joe: Yes, evaluate why you want to participate (e.g., is it an important disease area to you personally, or some other health-related reason) and assess if you have the time and effort required to fully participate (knowing this study was two years long). I didn’t want to be a study “drop out” as I know how that negatively impacts the data analysis/results and study cost.
Dave: Just do it. To me, it felt good knowing that I was contributing “to the good” for everyone. It didn’t matter to me if the vaccine even came to market, I wanted to be a part of the trial and the vaccine evaluation.
Erica: It can be a really fun experience to be on the precipice of what’s next and what could come. My research site has such a fun atmosphere, and they are so appreciative. While you need to weigh the risks for your personal situation, I think it’s 100% worth it!
