Clinical Trials: A Participant’s Perspective

While our Learn eCORE blogs often focus on compliance or ethical issues for those involved in the conduct or oversight of research, we thought it would be interesting to provide the perspective of a research participant. We recently spoke with Elaine Jones who participated in the 2020 Pfizer COVID vaccine clinical trial. Elaine has an extensive R&D background, giving her unique insight into her experience as a research participant.

Tell us a bit about your background:

I have a Ph.D. in microbiology with a specialty in virology and immunology. I started my career at SmithKline Beecham Pharmaceutical as a research scientist working on animal vaccines. I then transitioned to business development, followed by life science venture investing, first at GlaxoSmithKline and later at Pfizer Ventures. I retired in 2019 but remain active in the field by serving on the boards of several biotechnology companies.

Had you ever participated in research prior to the Pfizer COVID vaccine trial?

Yes. Early in my career, I volunteered for one small clinical study that involved donating biospecimens, but the Pfizer COVID vaccine study was my first time being a participant in a clinical trial.

Why did you volunteer for the COVID vaccine trial?

As COVID cases continued to grow in 2020, I was thinking about ways I could help when I learned that Pfizer was recruiting for a vaccine trial with sites in my area. Volunteering for this trial seemed like an important way that I could contribute to the fight against COVID.

Were there other factors that helped you make the decision to volunteer?

• I was familiar with the mRNA technology and had confidence that it was safe and had the potential to be quite effective.
• There were several participating sites in my area, including one that was convenient for me.
• Although I understood that some participants would get a placebo, I thought that if I was randomized to receive the vaccine, I would be among the first to get something that could potentially offer protection against COVID.

From a participant perspective, what aspects of the trial did you like or find particularly helpful or reassuring?

• Before starting, I spoke with the site staff about the general aims of the study and the eligibility criteria for participants. I met the initial criteria and was able to schedule my first visit, which included both a formal screening assessment as well as vaccination if I successfully met the inclusion/exclusion criteria.
• At my first visit, I received a packet of information about the trial including the consent form which I could also access electronically. I was afforded time to review all the trial information and spoke with both the nurse and the Principal Investigator to answer all my questions. I then chose to participate in the study and moved into providing a complete medical history followed by blood specimen collection and, finally, vaccination. As required, I had to be observed for 30 minutes post-vaccination to ensure that I did not have any adverse effects from the injection.
• While my initial screening visit took some time, everything was well-organized. The visit went more smoothly than I expected.
• The dedicated trial staff at my site were key. They were very knowledgeable about the trial and were able to answer my questions at enrollment and throughout the study. Interaction with study staff was especially important for the consent process.
• While the follow-up schedule was clearly explained to me, there was some flexibility for timing of follow-up visits which was helpful.
• Trial visits were scheduled in advance and helpful reminders were provided by phone.
• I did understand that the study was seeking at least some participants who were frequently out in the community (for example, because of their jobs). Because I am retired and was taking COVID precautions quite seriously, I was concerned that I did not fit that category. The study team assured me they were interested in participants from a variety of backgrounds and activity levels and there was absolutely no pressure on me to change my lifestyle or personal approach to COVID for the study.
• The trial made use of an app for participants to record symptoms. The app was easy to use. I was provided training during a site visit and the site staff were available to quickly resolve the few issues I had.
• I was a bit concerned about what would happen to participants if and when the vaccine was approved. I was told at the outset that the study blind (keeping participants unaware of the intervention they are receiving) would be broken if the vaccine was approved prior to completion of my participation in the trial. If I had gotten the placebo, I would have been offered the vaccine at that time. I was therefore very pleased that I was contacted very soon after vaccine approval by the U.S. Food and Drug Administration (FDA) and even more happy to learn that I had received the vaccine. In addition, I received a letter stating that I had received the vaccine; this was critically important in January 2021, as proof of vaccination was essential to have. At my next site visit, I was also provided a vaccine card with all the relevant dose and date information.

Were there any negative aspects of being in the trial?

• Despite my background, I found the consent form to be a bit daunting, largely because it was quite long (25 pages) and some of the details seemed overly complex. I worried about how participants coming from non-science backgrounds would navigate this form. Again, having knowledgeable study staff who could take the time to review all the details was critically important.
• The lengthy list of what seemed like every conceivable risk in the consent form was potentially off-putting and perhaps not as well contrasted with potential benefits. I am aware that this risk-benefit contrast is necessary, and I was not deterred by it. But I wondered if the lengthy list of risks might have turned-off other potential participants.
• The consent form did a reasonable job of explaining the randomization process, but I wondered whether participants would understand that they might not get the vaccine in this trial
• While the study site was convenient for me, it would have been preferable to have an option to get follow-up blood drawn at a more local site.
• While study staff were quick to let me know which arm of the trial I was in when the vaccine received approval from the FDA, I was not given any other clinical results, such as my antibody levels. It may be because of my background, but I thought it would have been useful to at least have the option to access my specific results from this trial

Would you participate in a clinical study again?

Absolutely! In fact, as part of this study, I agreed to let the site contact me about future research studies. I am currently enrolled in my third COVID booster trial but had to turn down another interesting study because the timing conflicted with other planned activities. What I really appreciate is that I never feel pressured to do other studies and I can also indicate what types of studies I would be most interested in. Surprisingly, the consent forms for these subsequent trials have gotten longer–up to 35 pages!

Any final comments?

Developing and implementing protocols is very different from actually being in a research study. Investigators would definitely benefit from taking the time to learn about the research experience from participants.