On Trial

Clinical research is an essential step in advancing medicine

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For North side resident Annie Campbell, the odds that she would beat breast cancer looked to be in her favor.

Campbell was diagnosed in October 2022 with HER2, an aggressive form of the disease. It was considered deadly until the early 2000s, when a treatment with a 95% cure rate was developed. Campbell, unfortunately, found herself in the other 5%. 

She was treated at Virginia Commonwealth University’s VCU Massey Comprehensive Cancer Center, undergoing six rounds of tough chemotherapy followed by surgery and radiation treatments. The surgery found residual cancer, which had spread to her lymph nodes. Campbell was eligible for a clinical trial at Massey, but she was reluctant to participate so soon after her initial treatment. Friends warned her that her type of cancer comes back, and that she would want “every layer of protection” she could have. 

Campbell thought about it, how all medical advances begin with trials. And then life intervened: One of her daughters was also diagnosed with breast cancer. Campbell volunteered to take part in the trial. “Once I decided to do it, I felt a connection with all the women who had ever been in trials and all the women in trials now,” she says. 

It was a standard of care trial, meaning patients received standard treatment for someone in Campbell’s situation with a medicine that was being tested for potential use. Like many trials, a portion of the patients received nonactive, or placebo, care. The study, which ended last March, involved 14 sessions of chemotherapy, an infusion of the trial medicine and chemotherapy pills twice a day, and “some pretty heavy radiation.” 

Campbell does not know whether she received placebo or the study medication, but she did end the trial in remission, which she says gives her “permission to live my very best life.” 

The ordeal was worthwhile. “I’m voting for my life,” she says. “I really didn’t look back.” 

Clinical trials are a crucial step in advancing medicine and saving lives. They are part of the process for getting new drugs on the market, whether that’s medication for people with diabetes or chemotherapy to treat cancers. Clinical trials can lead to new diagnostics, earlier detection of diseases, or refinements in treatments to make them more effective or less toxic. 

Trials are also a way for citizens to gain “access to tomorrow’s medicine today,” says Dr. Andrew Poklepovic, an oncologist and associate director for clinical research for the VCU Massey Comprehensive Cancer Center. 

With more than 20 years’ experience, Poklepovic says he has seen incredible advances in treating cancers thanks to trials. Early in his career, the survival rate from a diagnosis of Stage 4 melanoma was six months. Now, it’s five years. “I’ve seen patients start a trial and survive their cancer because of the trial,” he says. 

As the medical field in the Richmond region has grown, medical trials have grown with it. Local doctors, scientists and patient volunteers, such as Campbell, are key players in a lucrative industry that impacts treatments worldwide. 

The Cost of Cures 

Medical trials are a big business. In 2024, metro Richmond researchers were awarded $115.4 million in federal grant funding for clinical trials, according to the National Institutes of Health Awards by Location & Organization database. The bulk of that funding went to Virginia Commonwealth University grants, which totaled $111.9 million for 272 projects. (The NIH had awarded an additional $15.8 million to VCU for 42 grants as of late February.) Virginia State University in Petersburg received three NIH-awarded grants in 2024, valued at $89,962.  

Although the funding is substantial for the area, it’s a fraction of the money spent on research each year. The NIH — which provide the bulk of funding for medical research in the United States — approved $35 billion for 60,000 grants to biomedical researchers in 2024, according to ABC News. 

Further, American studies are crucial to advancing medicine across the globe. From 1999 through mid-2024, the United States accounted for about 21% (186,497) of all clinical trials internationally, according to the World Health Organization. China was second, with nearly 15% (135,747) of all trials, followed by India, with 74,031, or a little over 8% of trials. 

In February, the Trump administration announced plans to cap NIH funding for the indirect expenses incurred in research at 15% of grants. Researchers contend that limiting funding for support staff, maintenance, facilities and equipment could halt research. A federal judge in Boston imposed a temporary block on the plan, according to the Associated Press. The administration also blocked the NIH from reviewing new research grant applications, but by late February had partially lifted its freeze on the process. 

Overall, federal funding is crucial to the trial process, according to Dr. William J. Irvin Jr., Bon Secours Richmond’s clinical research director and director of oncology and an oncologist with the Bon Secours Cancer Institute at St. Francis Medical Center. “It would be devastating to lose that, and it would set not only the United States back, but probably the world back by a decade,” he says. 

Funding from industry players, venture capitalists and foundations plays a role in the later stages of drug development, but federal funding is critical at the beginning of the process. “That investment has a huge [return], not just for the patron community, for the centers in which we work, but also for the public health,” says Dr. Nicholas Johnson, division chief of neuromuscular and vice chair of research in the Department of Neurology for the VCU School of Medicine. 

Some local research is less impacted by political headwinds. At HCA Healthcare’s Richmond facilities, researchers receive more funding for their work from industry sources than from the government, so they are less vulnerable to changes in federal policies. “That allows us to continue to be very active and offer our patients and the Richmond population a lot of studies,” says Dr. Nayef Abouzaki, an interventional cardiologist with Virginia Cardiovascular Specialists. 

As of late February, HCA Virginia was accepting enrollments in more than 35 trials. Its research includes studies in prevention and interventions in acute disease, interventions in chronic and stable cases, and long-term follow-ups to prevent cardiovascular disease and its progression, according to Abouzaki. 

From Theory to Treatment 

For researchers and doctors, clinical trials are essential to delivering better care, says Dr. Patrick Nana-Sinkham, a pulmonologist and chair of the division of pulmonary disease and critical care medicine for the VCU School of Medicine’s Department of Internal Medicine. “When we see patients in clinic, every patient that we see, we think to ourselves, ‘Is this an opportunity to engage our patient in a new clinical study that may ultimately benefit them and benefit the patients to come?’” he explains. 

“Analysis is the main tool that we have to test, really, any new intervention that we want to make in taking care of patients,” he notes. “That may range from a new diagnostic test to testing a new drug to evaluating the way in which we deliver care, with a goal of trying to deliver better care. All of these are accomplished with clinical trials.” 

Nana-Sinkham adds, “[Research] is essential to providing the best care for our patients, not only today but tomorrow. We always want to place the patient first and give them the opportunity to benefit from the most innovative discovery that will improve their care.” 

The advancement of a new medicine from idea to approval may take a decade or longer. Laboratory testing — the basic science of determining if a treatment or medication may be viable — can take years on its own. It is followed by a Phase 1 trial, which investigates a drug’s safety in humans, and then a Phase 2 trial, which looks at whether the drug works. In Phase 3, investigators examine whether the treatment is equally or less toxic than the standard of care. 

Testing parameters must have a certain number of patients and clearly

show how many benefited or not, as well as those who experienced side effects. A treatment or medication can’t be approved in the United States without testing. “It all comes down to the risk-benefit ratio,” Abouzaki says. 

Dr. Michael Arcarese, an interventional cardiologist with Cardiology Associates of Richmond, a part of HCA Healthcare, believes that trials are the basis of the practice of medicine. He notes that cardiology is the target of more medical trials than any other field. “One of the things I love most about cardiology is that everything we’ve done has been done through [clinical trials],” he says. “We’ve sort of proven that it works.”

[Research] is essential to providing the best care for our patients.

—Dr. Patrick Nana-Sinkham, VCU School of Medicine

The HCA Research Institute, HCA Healthcare’s multispecialty research branch, provides the infrastructure for trials in HCA facilities in Richmond and helps connect the researchers with the funding, says Amma Agyemang, director of research for HCA’s capital division and a member of the HCA Healthcare Research Institute. Locations with research programs include Chippenham, Henrico Doctors’ and Johnston-Willis hospitals. 

Pharmaceutical and biotech companies will contact the institute regarding opportunities for trials, Agyemang explains. The institute then passes the information to its physicians to gauge their interest. At times, the companies will contact researchers directly, and they in turn work with the institute to move the process forward.

A Locus for Trials 

Richmond has become a top destination for clinical trials, but whether talent and money followed or lured the research is a bit of a chicken-and-egg question.  

Research centers such as the Children’s Hospital of Richmond at VCU and its Children’s Hospital Foundation represent an investment in enticing leading scientist physicians to live and work in Richmond, says Johnson, while Nana-Sinkham asserts that VCU and VCU Health are a “destination center for innovative research.”  

VCU offers a unique combination of assets in its clinical research base, including its medical center, the dentistry, business and engineering schools, and the Children’s Hospital. “This allows us the opportunity to build scientific teams that span a spectrum of research,” Nana-Sinkham adds.  

In addition, the region’s advancement is undergirded by a confluence of willing local participants and a strong medical network. “It really starts to come with population density and clinical scales,” Poklepovic says. “We are lucky to have [those] here in such great abundance.” He notes that Richmond is fortunate to have a well-developed health care system with three major players (Bon Secours, HCA and VCU Health) that all offer clinical trials, creating treatment opportunities that aren’t available elsewhere. “We all know that one of the best ways to treat patients is to put on a clinical trial,” Poklepovic says. 

Trial hosts identify the Richmond region’s residents — a diverse population with a track record of enthusiastic volunteering — as uniquely attractive for clinical research and a major reason that trials for COVID-19 remediations including AstraZeneca’s vaccine and Gilead’s remdesivir treatment came to Richmond in 2020. 

Population wise, this region has been among the fastest growing in the state since the pandemic. That residential boom has brought a greater need for access to trials because, as Bon Secours’ Irvin notes, with more people comes more illness. Growth and the area’s attractions — such as  new housing, great amenities, cultural and recreational opportunities, and a robust health industry infrastructure — suggest more trials are in store.

And we aren’t just Richmond famous. Progress has also drawn patients from farther afield, such as Brooklyn Garza, a 17-year-old with limb girdle muscular dystrophy type 2A.  

The disease impacts core muscles and steals mobility, which led Brooklyn to experience progressive weakness in her arms and upper thighs and left her with a waddling gait. She can’t run, jog or walk long distances. “I need help with basic things like getting out of bed, dressing and bathing,” she says. “I miss school for medical appointments, and I always have to consider accessibility, making sure there aren’t stairs everywhere I go, planning how long I can stay somewhere before I get too tired and figuring out whether I’ll have the help I need.” 

A Texas resident and advocate for people with the disorder, Brooklyn has come to Richmond and the VCU Medical Center twice to participate in a natural history study. The goal is to gather data to create a better understanding of the disorder’s prevalence in the population and its impact on people who have it. 

The Garza family signed up for the VCU study because Brooklyn was eager to work with Johnson, the VCU School of Medicine doctor who specializes in treating adults and children with neuromuscular conditions. He is also an active researcher, finding lab time each week to investigate genetic muscle disorders such as MD type 2A. 

“Dr. Johnson is a leading neurologist in the field,” says Brooklyn’s mother, Melina Garza. “[We] were definitely coming to see him.” Good data is the foundation of viable trials and treatments, so the Garzas were eager to participate. 

After her study session in February, Brooklyn was scheduled for a third round of testing in another year. She and her mother would like to see the schedule moved up. “Our hope and dream would be for her to get placed in a trial,” Melina says, adding that sooner would be better. If Brooklyn’s condition progresses to the point where she is unable to walk, it’s unlikely doctors could “bring that ability back to her.” 

Such trials offer hope to the Garzas and families across the world. 

Explains Johnson, “These are patients and parents who are quite desperate for something to change the course of [these] diseases and are willing to do almost anything to see if they can get access to one of these treatments.” 

Learn more: Ongoing studies play a role in improving the health of Richmond and the country. Finding a trial in the region starts with the National Library of Medicine’s online registry of active trials at clinicaltrials.gov.

How It Works 

Trials are used to test potential medicines, treatments or procedures. The National Institutes for Health define a clinical trial as a research study in a person or people in which subjects are subjected to the medication, procedure or treatment or placebo to evaluate effectiveness and safety of a product or procedure.

Researchers may stop a trial after Phase 1 or Phase 2 if the test procedure or product is unsafe or ineffective. If it proceeds through Phase 3, researchers examine and may publish the results for peer review. If those are deemed satisfactory, they may seek approval from the U.S. Food & Drug Administration. Development of a trial, from an idea to placing a medication or treatment on the market, may take 10 or more years.

Types of Trials

  • Behavioral trial: Evaluates a new way to encourage changes in how people behave to improve health 
  • Diagnostic trial: Evaluates a new way to diagnose a disease or condition 
  • Prevention trial: Evaluates a procedure that prevents a disease from recurring or from never developing in a person who has never had the disease or condition 
  • Screening trial: Evaluation of a novel way to look for a disease or condition 
  • Supportive care trial: Test of a procedure to improve quality of life or comfort of a person with a condition or illness 
  • Treatment trial: Testing out of a new way to treat a disease or condition

Trial Phases 

Trials are generally developed in a laboratory or from observations in a practice. Medications may be initially tested without human involvement. When they are deemed likely to be safe in humans, they proceed through phases. 

  • Phase 1: A small group (20-80 subjects) is involved in testing a drug or treatment to determine safety and possible side effects. 
  • Phase 2: The second round of testing expands to a group of 100 to 300 subjects to determine safety and side effects. 
  • Phase 3: An even larger group of subjects (1,000 to 3,000) is treated to confirm effectiveness and side effects. Phase 3 also involves comparison with standard or similar treatments. The trial treatment or procedure is submitted for approval to the U.S. Food & Drug Administration. 
  • Phase 4: A post-approval and post-marketing phase to track safety and seek more information about benefits and optimal use