When we take medication to recover from an illness or manage a health condition, we probably don’t think much about the process that medicine went through before it was available to patients.
The reality is, a lot happened with that prescription before it ever ended up in your medicine cabinet. The same is true for a therapy you might receive in a hospital and the vaccines we take to protect ourselves from serious illness. All of these treatments and interventions went through extensive research known as clinical trials.
According to the National Institutes of Health, “clinical trials are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device (for example, a pacemaker), is safe and effective in people.”
Privia Medical Group North Texas (PMGNTX) has physicians who participate in clinical research to not only help determine if a treatment will be effective in the future, but to also help their patients today. One of those physicians is Dr. James Harvey, a family practice physician with years of experience in clinical research.
A Life-Long Passion for Research
A United States Army veteran, Dr. Harvey became interested in clinical research during his residency at Fort Belvoir in Virginia. “One of the faculty members was conducting a study on a type of therapy for influenza,” Dr. Harvey recalls. “I got to help with the project, which led to my ongoing interest in clinical research.”
After the Army, Dr. Harvey established an office in Fort Worth and did some clinical research as he was ramping up his primary care practice. But it was personal tragedy years later that reignited his passion for medical research.
In 2019, Dr. Harvey’s wife was diagnosed with an aggressive form of colon cancer. The Harveys went to the University of Texas MD Anderson Cancer Center in Houston, considered one of the best places in the world for cancer care. There, Mrs. Harvey received treatment as part of a clinical research protocol.
“Being on the subject side for the first time, I was reminded how much I value medical research,” Dr. Harvey says. “It reminded me of the core mission of physicians: to improve our patients’ lives.”
Even in the aftermath of a terrible loss, Dr. Harvey found himself grateful for the clinical trial that had prolonged his wife’s life. He also felt driven to resume his own research. “I wanted to find new ways to help my own patients and other Privia Medical Group patients have access to cutting-edge treatments that would help them live longer and better lives,” he says.
Researching New Ways to Treat – and Prevent – Disease
Dr. Harvey has been involved in several key research projects recently.
One is on a new vaccine to protect against respiratory syncytial virus (RSV). This trial is evaluating a new mRNA vaccine to prevent the highly-contagious respiratory infection, which can be especially dangerous for the elderly and young children.
A separate vaccine trial involves a COVID-19 booster and mRNA flu vaccine, combined into one shot.
Dr. Harvey is also conducting clinical trials with patients who have suffered a major cardiovascular event, such as a heart attack or stroke. Specifically, this therapy is targeted towards patients who have residual risk of inflammation after a cardio event, as well as patients who have sustained lipid risk (elevated cholesterol levels) that is not responding to statins alone.
Clinical trials involve hundreds of separate studies around the world. The duration and number of patients involved in trials overseen by Dr. Harvey varies. For vaccines, there are usually 50-100 patients involved in a two-year trial. For a cardiovascular treatment, there are five to ten patients in a trial that could last three to five years.
The Patient Experience
“Is it safe?”
Understandably, that’s usually the first question a patient asks Dr. Harvey when he suggests a clinical trial might be beneficial. “That’s why I try to head off the question by assuring patients that a clinical trial is safe,” he explains.
Dr. Harvey does not conduct Phase I trials, the initial studies that determine the safety of the therapy. He engages in Phase II and Phase III studies, which are only conducted after the treatment has been determined to be safe and there is some indication that it will also be effective.
For each patient participating in a trial, Dr. Harvey tracks a range of data. Some are quantitative – such as lab results – while other information is qualitative, such as tracking how the patient is feeling.
“There is no blood test to find out how someone feels,” observes Dr. Harvey. “In today’s studies, the drug manufacturers really want to get a good picture of the patient’s experience. Trial participants are provided with an app in which they can log their experience and tell us how they are feeling. If they don’t already have a smartphone, we get them a device.”
The Physician Experience
Dr. Harvey points to several factors that make clinical research appealing to him as a doctor.
“It’s been very satisfying to be able to do this work,” he says. “It also helps me stay current with the latest treatments. I know what’s coming.”
For Privia physicians, the process is made easier thanks to the group’s partnership with Javara, an Integrated Research Organization that specializes in getting “cutting-edge care to patients who need it” by making clinical studies more accessible and efficient.
Dr. Harvey credits Javara for making his research possible. “Javara handles the administrative support and staffing, which allows my staff and me to continue focusing on our patients,” he explains.
Asked what advice about clinical research he would give to a young physician just getting started, Dr. Harvey says, “Clinical research is a great way to fill in your practice. If you love learning and being able to answer questions, if you like the idea of providing therapies years before they are available to the general public, then it’s definitely something you should consider.”
“If you went into medicine because you want to help people, this is a great way to help,” he continues. “There is a sense of pride, knowing you were part of that process. Even if the therapy you are researching ultimately doesn’t work, you have still helped medicine move forward.”
A Desire to do Something Meaningful
Asked if his service in the Army has informed or shaped his approach to medical research, Dr. Harvey says, “Yes, in a couple of ways.”
“One, the military teaches organizational skills that are necessary to conduct good research. I rely on things I learned in the Army,” he explains. “Second, there is the sense of purpose you have serving your country in an all-volunteer military; that same mindset leads me to want to do this work. It’s rooted in a desire to do something meaningful.”
And meaningful work it is.
“We don’t get advances in medicine without this work,” Dr. Harvey says. “We – as physicians – have that responsibility. If there is no research, there are no new therapies.”
This article has been reviewed and approved by a panel of Privia Medical Group North Texas physicians.