As the COVID-19 pandemic has persisted around the globe, clinical trials have also become a mainstay in the news, with several companies conducting clinical studies for potential vaccines and treatments for the novel coronavirus. This includes Johnson & Johnson, which currently has an investigational COVID-19 vaccine candidate in Phase 3 clinical trials known as ENSEMBLE.
Phase 3 clinical trials are research studies conducted with large and diverse groups of people to evaluate whether a medical device, drug or treatment regimen could potentially be effective as a new option for patients.
The studies are generally randomized—which means one set of people gets the investigational treatment and another gets a placebo, usually a sugar pill or a shot filled with a salt solution—and double-blinded, which means neither the participants nor the researchers know who is receiving the vaccine and who’s receiving the placebo.
If the medication or device is determined to be generally safe and effective, and the benefits outweigh the risks, it might then be approved by a regulatory body, like the U.S. Food and Drug Administration (FDA), for public use.
That’s what happens on the science side of things. But what is it actually like to be enrolled in one of these studies?
We asked three participants to share their stories about what the process was like—and how it felt to be on the cutting edge of medicine.
“I’m in a clinical trial for an investigational COVID-19 vaccine”
Jim Anzalone, 71, Baltimore, Maryland
“I am a firm believer in science and research. I was a psychology major in college and my wife was a research coordinator for a research institute here in Baltimore. For 10 years, I worked as the medical liaison at the Baltimore County Detention Center.
One of the things I wanted to do when I retired was to be part of research studies. A few months back, I saw an ad looking for people to take part in a coronavirus vaccine study. It was specifically looking for people aged 65 and older—I’m 71, although I think of myself as younger because I exercise a lot and I’m active. I was very interested and saw it as a way of doing my part during the pandemic.
I met the doctor in charge, who asked if I had any questions. I wanted to know about the results of the first stage of the study—I am part of the combined second and third phase. Everyone was transparent about the known side effects, which seemed to be soreness in your arm at the injection site and a low-grade fever. I was also given the data to review. And there was about two hours’ worth of paperwork to fill out, including consent forms that went over the potential risks.
I have to go back for blood tests at months six, 12 and 24. I was also given access to a phone app to report weekly whether I have any COVID-19 symptoms.
Before I got the shot, a nurse drew my blood and gave me a nose swab to test for COVID-19. Three weeks later, I went back and did those things again. I have to go back for blood tests at months six, 12 and 24. I was also given access to a phone app to report weekly whether I have any COVID-19 symptoms.
The doctor told me not to make any assumptions that I’d be protected from the virus because I could have gotten the placebo—I knew I had a 50% chance of that. So I was told to take the regular precautions: wash my hands, wear a mask and stay six feet apart from people, which I was already doing. I also couldn’t get a flu shot until 28 days after the second shot.
I thought the process was very good, very professional. I was impressed by it all. I’m now being considered for future Alzheimer’s studies—my mom died of the disease. I’ve had blood work and a cognitive test done, and I will have a PET scan on my brain to look for plaques and tangles, which are some signs of the disease. Based on the results of the screening, I may then be asked to participate in future clinical trials.
Scientific research is critical for future generations to prosper. I think it is so important that I’ve encouraged friends to consider participating in a research study—it’s a wonderful way for us old guys to contribute.”
“I’m in a clinical trial for an investigational psoriatic arthritis treatment”
Danielle Askin, 37, Brooklyn, New York
“I started having symptoms of psoriatic arthritis when I was 20, but when I complained that my joints hurt, my doctor said it was from sports, and later, that I was just getting older. I wasn’t diagnosed until I was 30.
I tried all sorts of medications before finding a treatment that worked, but getting it regularly became too much of a burden. Every two to three months, my health insurance would require me to get a pre-authorization. It would take a long time, and I would miss a lot of shots. So I was in a lot of pain.
Then, in the fall of 2019, I heard about a clinical trial for an investigational biologic treatment that I could potentially take regularly. This biologic works by targeting the immune cells that cause psoriatic arthritis.
The study was taking place at the New York City hospital where I was already being treated. I had to fill out a lot of paperwork and questionnaires. Once I got approved, I received packets of information about the first two stages of the trial. I had a lot of concerns and questions, and because I have young kids, it’s important that I manage my risks. I also would have to stop taking the medication I was on. It was a risk, because I knew that I could get a placebo in the trial, which could potentially mean I’d be in some pain.
But I received enough information that I could do my own research in scientific journals. I also talked directly to the trial doctor, who explained that the medication was a new form of an already-approved medication and had already gone through two stages of testing with thousands of people. That really eased my tension.
I really appreciated having access to such high-quality healthcare, which has been an upside to doing a clinical trial for me.
I started the study in February 2020. The following month, New York City went into lockdown for COVID-19. I still had to go to the hospital for a shot every month, but the study paid for a car to take me there and back to my home in Brooklyn, so there were no out-of-pocket expenses.
Over the summer, when I came in for my last shot, I was told that the study was moving into the second stage of the third phase and was asked if I wanted to continue. I said, ‘Absolutely.’ Now I do the shots at home for three months and only go to the hospital every three months.
But the exam process is still the same. Once I’ve gone through the COVID-19 restrictions at the hospital, a nurse takes my vitals and a blood and urine sample. Then I spend about a half hour answering questions about how I’m feeling, physically and mentally.
After I’ve filled out the questionnaire, I see a doctor, who does a thorough exam to check if my indicators of inflammation have gone down. He checks all of my joints. He checks my fingernails, because psoriatic arthritis causes pitting. He looks for patches of psoriasis. He’ll ask how I’m doing and feeling. Then I’m given this gigantic cooler with my shots to take at home. And if have any problems, I can email the study nurse and she’ll call me.
When the pandemic first happened, I felt really, really down because my kids were home doing virtual school, I was trying to work full-time, and my husband was home full-time too. When the doctors saw that, they wanted me to stop the trial. I had to go to a specialist and get another, more thorough, evaluation before they would let me continue, because they wanted to make sure that my mood was not a result of the medication.
I really appreciated having access to such high-quality healthcare, which has been an upside to doing a clinical trial for me.
“I was in a clinical trial for an investigational pulmonary arterial hypertension treatment”
Irasema Santos, 56, Norwalk, California
“The first clinical trial I enrolled in was for a daily pill to potentially treat pulmonary arterial hypertension (PAH)—a type of high blood pressure that damages the blood vessels in your lungs and the right side of your heart. It was 2004 and I was newly diagnosed with the condition at the time.
With this disease, you’re short of breath all the time. I couldn’t even shower easily, because I couldn’t raise my arms from the lack of oxygen. I’d always been an athlete, a roller blader. But I’d taken fen-phen, a diet pill, and I believe this is how I may have gotten the disease. There are other reasons why people may develop pulmonary hypertension, including genetics, but taking fen-phen has been linked to an increased risk for developing PAH.
I was referred to Harbor-UCLA Medical Center in Torrance, California, where I met Dr. Ronald Oudiz, who is an expert in PAH. I was lucky to have landed there. I found out about that first clinical trial at his office.
My main concern was whether it would make me gain weight. They told me there was no known weight gain. But side effects might include loose bowel movements, maybe some nausea and headache. Luckily, I didn’t experience any of those effects.
Being in that first clinical trial gave me hope that maybe there are medications that can help me feel somewhat normal. I know I’ll never be 100%, but I can be close to it.
Before the study started, I had a heart catheterization done, in which a thin tube is inserted in the jugular vein that goes into the right chamber of the heart and a vein in the lungs. It’s a way for doctors to tell how medications are affecting your PAH. I got other procedures too, including EKGs and pulmonary function tests.
During the study, I went for check-ins, where I’d have to answer a long questionnaire about my psychological state—‘How are you feeling?’ Are you depressed?’—and physical activity—‘What kind of exercise did you do? Were you able to make your bed?’—because those things are hard for people with PAH. I also got blood work and other tests to assess my lung function.
The investigational medication was being studied to determine whether it could open up your cardiovascular valves to get better blood flow, so you get better oxygen. Ultimately, the treatment got FDA approval, and after the trial, I was able to stay on it for free. Since then, I’ve also been in other clinical trials for drugs or devices that might help treat pulmonary hypertension.
Being in that first clinical trial gave me hope that maybe there are medications that can help me feel somewhat normal. I know I’ll never be 100%, but I can be close to it.”
