What My Experience in a COVID-19 Vaccine Trial Taught Me About the Need for Greater Patient Centricity

Kelly McKee, Vice President of Patient Registries and Recruitment at Medidata, recently participated in a COVID-19 vaccine trial. Despite over two decades of experience in clinical trial operations and patient recruitment, this was her first experience as a patient. In this first-person blog, Kelly reflects on the many opportunities clinical trials still have to become more patient-centric.

I’ve spent my career in clinical research. I champion the benefits of participation to anyone who will listen, and many who won’t. But until last year, I had never participated in a randomized, double-blind trial. It’s not that I didn’t look for opportunities. As a healthy individual with many priorities (work, kids, etc.), it just never seemed like the right fit or the right time.

In 2020, everything changed. I’m an extrovert by nature and being quarantined was hard. Not as hard as losing a loved one to COVID-19, or being hospitalized myself, but it was hard feeling trapped, not seeing friends and family, and feeling hopeless. When I learned there were several vaccines in development for COVID-19, I immediately wanted to be a patient in a study. I knew it was finally my time—the right time—to get involved.

Finding A Trial Isn’t Easy

Even with my experience in patient recruitment, it was hard for me to get into a clinical trial. Finding and enrolling in a trial was difficult. I started with clinicaltrials.gov, searching through the records, finding only cities and states of participating sites, but little else that would help me start the process of enrollment.

Eventually, I found a participating hospital in Boston, but without the name of the Principal Investigator (PI) or Study Coordinator (SC). I called a personal friend, a physician at this hospital, who was able to identify the PI. I contacted the PI through email, who thankfully responded, and I was eventually put in touch with the SC for screening. The screening phone call was awkward as the SC read from the IRB-approved script. It didn’t flow like a conversation and was difficult to understand. If I wasn’t familiar with the process, I would have assumed something was wrong and might have hesitated to continue.

My Clinical Trial Introduction

At the study site, the staff were friendly and appreciated my participation. The robot-talk of the IRB-approved screening script was gone…thankfully. The SC and Sub-Investigator spoke to me about the trial, the vaccine candidate, and study visits. They told me what to do if I had COVID- 19 symptoms (self-swab, call a courier, etc.) and answered all my questions (no, we don’t know when you’ll be unblinded; no, we don’t know if you’ll receive the vaccine if you’re randomized to the placebo arm; no, you won’t get any test results back, including positive COVID-19 test results from your self-swab). The answers made me feel like my participation was only for the Sponsor—there was nothing in it for me. And that didn’t feel great. But I knew that without clinical trial participation, there would be no vaccine. I wanted to be part of the solution.

Informed Consent

It was time to consent. I was handed an iPad and asked to watch a video explaining the clinical trial. The video was cute—the animations were nice, and the material was presented in a straightforward manner. I completed the knowledge check and provided my consent to participate—and then the tech broke. The iPad wouldn’t transfer my information. After 20 minutes or so, the site gave up and handed me a paper copy of the consent. “We hate this eConsent. It breaks all the time,” they told me.

Ongoing Participation

After undergoing the appropriate procedures (urine pregnancy test, nasal swab, blood draws), I received instructions to download an ePRO app (electronic Patient Reported Outcomes). This was a questionnaire I was to complete regularly, to track vaccine side effects or COVID-19 symptoms I was experiencing. I was given the choice to use my own iPhone or receive a device from the site. I’m a one phone kind of girl, so I opted to download the app on my own iPhone.

The app was straightforward, despite incorrect grammar and a rudimentary user interface, and it seemed to work. I received regular alerts to complete the questionnaire until after about nine months when the notifications stopped. Without the notifications, I admit that I sometimes forgot to complete the questionnaire. I called my site and was told this was a known problem with the app and that I was doing a good job remembering on my own.

I wondered about other patients—were they remembering on their own? Were the notifications working for them? For ongoing study visits, I was to head back to my study site in South Boston, typically a 35-minute drive from my house. There were no phone call check-ins and no opportunities for video visits. Every visit would require me to drive into South Boston regardless of what was going on in my personal life at the time.

Patient Stipends

I received a reloadable debit card for my participation and after each visit, a stipend was automatically loaded onto the card. Actually, I received multiple cards as the study card was not “ready” at my first visit. I asked the site if I could transfer the balance and consolidate on a single card and was told no. Determining the balance on my card was difficult. I visited the website printed on the back of the card. I didn’t have the PIN needed to view my account (a PIN? I didn’t remember receiving one), so I called the number on the website… turned out, that was the wrong number. I started counting my steps to view my balance. Twenty steps later—that’s right, twenty—I had a balance. I’d like that hour of my life back!

What I Learned

Having worked to improve the patient experience in clinical trials for over 20 years, I wish that my own experience reflected a more positive one. Unfortunately, there’s still much room to improve the patient experience in clinical trials. The whole trial seemed set up to extract information from me, providing very little data back, and not taking sufficient steps that might help ease the burdens placed on me.

My experience has only convinced me further of the importance of the work we’re doing to help Sponsors and CROs improve the clinical trial experience. When technology is built for patients by patients, like myMedidata, the whole patient experience becomes easier, less frustrating, and dare I say enjoyable. By using technology as an engagement tool, we can move beyond clinical trials as being transactional, focused only on collecting data. Patients are people and need to be engaged and appreciated.

That’s why we created myMedidata Registries—so individuals can learn about opportunities, be matched to a trial, and really prepare for participation. And once in a trial, myMedidata eConsent, myMedidata eCOA and ePRO, myMedidata LIVE, as well as sensors and wearables, can be used to enhance the patient experience and ease the demands on a patient's time. Post-trial, myMedidata Registries can be used for patient data return, engaging patients long-term, and making them aware of other opportunities. Using one platform, patients can have one ID, be followed long-term, continue to be engaged, and use technology as a tool for engagement and optimization of their clinical trial experiences.

If we want to improve the time it takes to bring new drugs, vaccines, and devices to market, we need to make clinical trials accessible to more people, and we need to optimize their experiences. There’s a history of clinical trial experiences that is far from optimal. We really need to be ambassadors of clinical research. We need to do things the right way. Little things that you think might not make a difference actually do.

Would I Do it Again? YES.

I was so happy I was part of a solution in bringing a vaccine to market. With the eyes of the world on the development of the vaccine, I think more people understand clinical research now, but we still have a long way to go. I want to make clinical trials better so that each patient’s experience is great, and more people want to participate. But we’ve got a long way to go, and we need to make the right choices along the way. Technology is one of the tools that can greatly impact clinical trial experiences.

Please click here to see some short videos on more real-life patient experiences