A Research Story: A Unique View from Both Sides
Editor’s note: Thanks to my role on the Lilly Clinical Innovation team, I have the pleasure of meeting various people who are involved with or interested in clinical research. This past summer, I met someone with the unique perspective of seeing it from two very different sides: he has worked in clinical research for over 10 years and last year he participated in a clinical trial. He agreed to share his experience with us, with the caveat that he be allowed to remain anonymous. The study was not a Lilly-sponsored trial.
Choosing to participate: seeking his own care options
How did you decide that participating in a research study was the right path for you?
I’m a relatively healthy male, but I have kept a close watch on my blood pressure and cholesterol because my father died of a heart attack when he was just 59 years old. When diet and exercise were no longer enough to manage my levels, I went to my primary care physician to ask about treatment options. He prescribed a statin, but in my connection with clinical research I was aware of a new class of drug being studied, and I wanted to learn more about it. So I held off on filling the prescription and instead called a local clinical research center to ask about research options. As it turned out, that center—which was only 5 miles away—was conducting a cholesterol study that was a good fit for me.
So you found the research study on your own. Your primary care physician didn’t offer that as a potential care option for you?
Not only did my PCP not mention research as an option, when I told him I was considering participation, he was not supportive. I felt comfortable with the choice I was making because I understand the process better than my PCP does. But I realize most patients who don’t already have that knowledge and confidence about research may not be so bold as to go against their doctor’s advice.
How much time passed from your first contact with the clinical research center until your enrollment in the study?
About a week. They were able to conduct a pre-screening visit during that first phone call—just a few simple questions to determine if I might be eligible—and they scheduled my full screening visit for just a few days later. I read and signed the informed consent during that first office visit.
That seems pretty fast!
Well, when patients are seeking a care solution, it’s important for them to get answers quickly. I was very pleased with my interactions with the staff at the research center. They were informative and efficient, and I felt like I was receiving the best possible care.
The informed consent: an essential step
So let’s talk about that first office visit. The informed consent marks a key entry point into clinical research. What was that process like for you?
My first impression at the site was a good one because I was in the waiting area for just 5 minutes before they called me back to be seen. That standard was true throughout the whole study—I never had to spend much time in the waiting room—and that became a key factor in my overall satisfaction. If I had had to wait an extended amount of time at each visit, I might have withdrawn from the study. During that first visit, the study coordinator did the necessary blood draws to be sure my lab values were in the range required by the study inclusion criteria. I thought that first visit would take about an hour and a half, but it ended up taking 3 hours. The informed consent document was 40 pages long, and I made a point of reading every word, which took about an hour.
So it was a paper document, not an electronic informed consent? We’re beginning to pilot use of an eConsent with some Lilly studies.
Right, it was paper. Most research sites aren’t using an eConsent yet. I did wish they had emailed me a pdf version of the document after my prescreening phone call so that I could have read it at home and kept that first office visit shorter. When I read the informed consent, I found out the study drug was an injectable. That wasn’t a deterrent for me, but I know it would be for many other patients, so I think the site could have saved itself and potential participants some time if they had shared that up front. I also learned the study design: a randomized 12-week period where I might get either placebo or study drug, followed by an extension of several months during which I would definitely receive study drug.
During the trial: a high level of care but room for improvement
Once you signed that document, you were in the trial for months. Tell us about how those office visits went for you during the study.
As I mentioned, the research center was only 5 miles away, and parking was convenient, so getting to and from the site for my visits was easy. One thing I really liked was that the site staff sent me reminders for my next visit via text message and phone call. Getting those reminders was very helpful.
Did you feel like you could always get your questions answered during the study?
Yes, the site was very responsive to any questions I had and returned my calls either the same day or the next day. I even had the primary investigator call the medical monitor at the sponsor company once to get the answer to one of my questions. So I felt like I had a lot of support right from the source.
That’s great to have that kind of responsive care. Was there anything during the trial that you thought could have been done better?
I was surprised when, on one visit to the research center I was informed that it would be my last visit. Up until then, the site had been really good at helping me know what to expect next, but I didn’t know that would be my last visit until I got there that day. It just seemed inconsistent with how they had been up to that point.
After the trial: the story continues
So was that it? Suddenly the study was over?
Well, not exactly. It turns out the sponsor had added a second long-term extension available to participants who wanted to continue receiving treatment. It’s just that the research center I had been going to chose not to participate in that extension. So I again made a few phone calls and was lucky enough to find another research center not too far away that was participating.
That does sound lucky. And it sounds like something most people might not have the resources to pursue.
That’s right. I had to seek it out for myself, and I’m not sure how many other patients would realize they could do that.
So now you had to get used to going to a new research center and interact with new staff.
True. I was very motivated to continue participation, so it wasn’t a big deal, but the new research center was farther away and parking was a hassle. Some of my office visits were simply to check my vital signs and to give me a new package of study drug. So I was spending an hour and a half, including travel time, for a 10-minute office visit. I know that you at Lilly are looking into how those kinds of simple office visits could be done as a remote or televisit, and I’m intrigued by that. I think that kind of flexibility is great from the patient point of view.
Two other things we’re trying to do better in Lilly research studies is share patients’ data with them and make sure they feel appreciated for their participation. Did you have access to your study data? And did you feel appreciated for volunteering?
I did get my lab data throughout the study, including my cholesterol results. As for feeling appreciated, I received a small compensation for my time and travel, and I always felt like I was a central part of the study. I received a high level of care from highly qualified staff.
Thanks so much for sharing your clinical research experience with us. And thank you for being a research volunteer.
You’re welcome. It feels good to participate not only to improve my own health but also to help potentially make a new class of medicine available for others.
To our readers: if you'd like to learn more about clinical trials or see if there's a trial that's right for you, explore our Lilly TrialGuide website.
Blog post originally appeared on LillyPad.