When Clinical Trial Professionals Participate as Subjects

Many of us working in clinical operations often put the patient at the forefront of study design and execution. However,many of us have not participated in clinical trials as subjects and have no idea what it is like to go through the system to participate in clinical research. In this interview, Jane Myles, Director of Decentralized Trials at Covance by LabCorp, and former Head, Operational Intelligence and Innovation at Roche, discusses her journey as a clinical trial participant.

Moe Alsumidaie: Describe your experience participating in a COVID trial.

Jane Myles

Jane Myles: Being in a COVID trial was essential to me for several reasons. I needed to feel like I was personally doing something to make a difference in finding a way through the pandemic. I wanted the experience of being in a trial, and it’s been hard to ever participate in a trial because I haven’t been ill, fortunately. So this was an opportunity where I could make a meaningful difference as a healthy volunteer. It was a way for me to think about how I would design a trial differently; as a clinical trial professional, I’ve always thought about operations from a theoretical perspective; being a patient in the trial helped me think about trial design differently. I believe all clinical trial professionals should experience what it is like to be a trial participant, and ‘learning by doing’ has provided insights I would never have gained otherwise.

MA: for a patient, navigating the steps required to participate in a clinical trial can be challenging. As someone who works in clinical trials, what was it like being a patient navigating the system to participate?

JM: Getting into the trial was more challenging and more demanding than I had imagined; even in a time of great need, with technology support to funnel the participants who were expressing interest, it took much persistence on my part. I had to follow through more than once to ensure that the research site and the sponsor knew that I was interested in participation. I was watching when the sponsor was going to open up the trial to participants by researching it in clinicaltrials.gov, triangulating where the sites would be, where I might be able to participate, and then contacting several sites directly, the recruitment vendor, and the sponsor. It took engaging three parties and multiple repeat follow-ups to participate. So, despite my clinical project management experience, I still faced challenges to participate; I can’t imagine what it must be like for prospective patients who have no idea how the system works. The lesson for me is that we have to make it easier for people who are willing to find out if they can be in the trial, and be mindful of providing them answers as quickly as possible to move them on to the next decision point. We need to make it easy for willing paticipants to get clear answers fast.

MA: What does it mean to have privilege when partaking in vaccine research as a participant?

JM: Privilege means having an advantage over others to partake in clinical trials. For example, simple things, such as internet access and having a smartphone to conduct ePROs. And there’s that level of knowledge that people with privilege have, such as understanding what a clinical trial is and knowing how to find where a study is being conducted. I work on clinical trials every day, so my team and my manager understood what it meant when I asked to take time away from work to participate, and they supported it with no questions asked. That’s privilege. Even educated and privileged people who do not work in science have misconceptions about clinical trials. For example, some people have asked me whether the vaccine will make me sick by exposing me to the virus. However, it was humbling to know that many people called me a hero by participating in research. That’s not why I entered or am sharing my story.

MA: What can be done to combat misinformation about vaccine research circulating on social media?

JM: I believe that patients have to be their champions to spread truthful information about clinical trials and vaccine research, especially in underserved communities. I decided to use social media to create more awareness around the trial process’s rigor; if you follow me on LinkedIn or even Instagram, you’re going to see that I’ve been posting every time I have a study visit, or there’s a study procedure, and it’s not about glorifying my participation, it’s much more about making transparent, what does trial participation look like? What does it mean to be unblinded? Was there rigor in the process? How did that happen? What was it like to learn you were a placebo patient? By spreading information about clinical trial participation, I hoped to raise awareness and trust in the system, and it worked; my followers got curious—lots of people reached out to me with questions.

MA: What was it like experiencing clinical trial decentralization as a patient?

JM: The trial I’m in uses ePROs to track my symptoms regularly, and I learned that my answers resulted in a definite trigger to the site to initiate a second level safety monitoring element in the trial. During my participation, I showed symptoms that were COVID-like, and I put it in my electronic diary via my smart device, and within a day, the site contacted me asking me for details about my symptoms. So, I registered my symptoms electronically, the site got flagged, they contacted me by phone and initiated a direct patient shipment to conduct a self-administered COVID test, which I had never experienced. It was an excellent opportunity for me to experience this first-hand as a patient, rather than being the person who designs the trial’s operational aspect. It all came full-circle when I started seeing the result of good clinical operational design as a patient; How does the signature work? Who gives me what materials? Who shipped the COVID test? How do I know where it came from and from which vendor? All those things became real, and I was pleased that it worked so seamlessly. As a clinical trial professional, experiencing what it is like to be a study patient helps me appreciate how important it is to contribute towards good quality by design that’s easy to use for seamless operations.
If I could design the trial from scratch, there might be some more decentralized solutions I’d use, since that’s my passion. But, I understand that, from a sponsor’s point-of-view, speed and simiplicity are key to success, and we all benefited from those principles—We have vaccines available in record time!

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.