By Jeff Kelley 

At Virginia Commonwealth University and VCU Health, clinical trials serve as the critical link between scientific discovery and patient care. 

Because VCU Health is an academic health system, many physicians and specialists don’t only treat patients. They also conduct research — some of which can lead to new drugs, devices or therapies that can improve or save lives. But for those treatments to ever reach patients, they must be thoroughly tested, which requires trials involving people. 

“The ultimate goal of all of our research is to develop new treatments for disorders, and the way we do that is through clinical trials, because that’s how we test new treatments to make sure they are effective,” said F. Gerard Moeller, M.D., a VCU School of Medicine professor who directs the C. Kenneth and Dianne Wright Center for Clinical and Translational Research. The Wright Center provides the infrastructure and resources that support VCU investigators to conduct interdisciplinary human health research. 

“Clinical trials are the ultimate extension of translation from basic science to actually improving the health of the community,” Moeller said. 

Hundreds of trials from multiple sources 

VCU and VCU Health host nearly 700 active clinical trials at any given time. The types of trials span disciplines from cardiovascular disease, cancer and pulmonology to gene therapies and diagnostics. 

Clinical trials originate from two main sources. 

• Investigator-initiated studies, often funded by the federal government and National Institutes of Health, are where VCU researchers test novel therapies or explore new uses for existing drugs or molecules. 
• Industry-sponsored studies, typically later-phase trials designed to generate approval data, where pharmaceutical companies partner with VCU to test drugs, devices or diagnostics.  

About three-quarters of VCU’s trials are industry-sponsored, with the remainder driven by university investigators testing their own discoveries or those from researchers at peer institutions. The goal of a clinical trial is to show the drug or device is safe and effective for its intended use and gain approval for sale by the U.S. Food and Drug Administration. 

How VCU Health patients benefit from clinical trials 

Many patients turn to VCU Health with complex diagnoses. 

“Those patients come to us seeking out the most advanced diagnostic, preventive and therapeutic interventions,” said S. Patrick Nana-Sinkam, M.D., associate vice president for clinical and translational research at VCU Health System. “We can offer many of those with approved medications and procedures, but clinical trials allow us to offer additional promising interventions.” 

Because the university-based health system serves such a diverse patient population, pharmaceutical companies find the health system attractive for ensuring their drugs and therapeutic interventions reach people with a wide range of conditions, Nana-Sinkam said. 

“Clinical trials increase our visibility as a destination for patients,” he said. 

VCU has seen an 86% growth in sponsored research funding since 2018, including a $144 million increase on the health sciences campus and a $55 million increase on the Monroe Park Campus. The VCU Office of the Vice President for Research and Innovation reported more than $500 million in sponsored research funding at VCU for the first time in fiscal 2025. That funding fuels the design, launch and scale of clinical trials. 

Cancer, for many people, is a life-altering diagnosis. For some people, it’s a feeling of betrayal, as if your own cells have turned against you. That feeling sets a certain determination inside of many patients: They want to fight, and clinical trials are the way to get to that forefront of optimal care. 

Keri R. Maher, DO, a hematologist and medical director of Massey’s Clinical Trials Office 

VCU Massey Comprehensive Cancer Center represents one of the largest selections of cancer clinical research in Virginia and conducts Phase 1 trials, which focus on safety and early signs of efficacy (Phase 2 trials expand to a larger group of participants to evaluate effectiveness, while the final Phase 3 trials involve hundreds or thousands of patients to confirm efficacy, monitor reactions and gather the data needed for FDA approval and clinical use). 

As one of only two National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in Virginia and 57 nationwide, the designation allows Massey to offer adult and pediatric patients access to more than 100 cancer treatment trials, in addition to studies that span from screening to survivorship.  

The process for selecting a clinical trial? Rigorous. 

No trial begins without a comprehensive review. The process starts with a disease expert who evaluates whether the trial addresses a gap in care, followed by a resource review and then scrutiny by VCU’s Institutional Review Board — a team of faculty, students and staff representing both the Monroe Park and VCU Health Sciences campuses. 

“While you can never completely guarantee that a study is going to be safe, there’s input from many individuals on the university side and the health system side to try to ensure that a clinical trial can launch safely,” Nana-Sinkam said. “What you can do is ensure that patients understand what they are getting into and what the risks are. That’s important: informed consent.” 

Even after approval, trials are tracked for safety, recruitment challenges and protocol compliance. 

Cancer clinical trials: A distinct model at Massey Comprehensive Cancer Center 

Clinical trials are a key tool in the fight against cancer. The disease’s complexity and urgency make trials part of the treatment pathway, not an afterthought. 

“Cancer, for many people, is a life-altering diagnosis,” said Keri R. Maher, DO, a hematologist and medical director of Massey’s Clinical Trials Office. “For some people, it’s a feeling of betrayal, as if your own cells have turned against you. That feeling sets a certain determination inside of many patients: They want to fight, and clinical trials are the way to get to that forefront of optimal care.” 

Every medicine, surgical procedure and therapy used as a standard of care to treat cancer exists because they were first proven effective in clinical trials. Cancer patients who participate in clinical trials receive first access to the latest, cutting-edge advancements that could become a new standard of care. 

“That’s what’s different about clinical trials with cancer compared to other diseases, where trials aren’t seen as frontline care,” Maher said. 

Keri R. Maher, DO, Massey’s Clinical Trials Office, notes that clinical trials are on the “forefront” of the best patient outcomes for treating cancer. (Phillip Newsome, VCU Massey Comprehensive Cancer Center)

 In addition to pharmaceutical sponsorship in investigational drugs, many of Massey’s clinical trials stem from internally developed discoveries by VCU researchers and peer NCI institutions. Researchers study new molecules and compounds, or new uses for existing drugs. It participates in trials addressing all phases of the cancer spectrum: prevention, screening, and treatment trials through survivorship. 

The center’s Clinical Trials Office includes specialized teams for operations, regulatory affairs, data management and investigator-initiated research support — a structure that allows staff to narrowly focus on specific trial functions. As one of only 57 NCI-designated Comprehensive Cancer Centers nationwide, Massey integrates basic, translational and clinical scientists “to bring molecules from bench to bedside and back again,” Maher said. 

Building trust with patients and expanding opportunities for clinical trials 

Both Moeller and Nana-Sinkam acknowledged challenges in an era of some public skepticism toward science and medicine. 

“We are trying to do a better job of getting out into the community, understanding what is important to them, listening and then testing interventions they would like to see,” Moeller said.  

The older [recruitment] model of putting up a sign and waiting for patients is not effective anymore. We have to meet patients where they are — in their communities, physically and mentally.  

S. Patrick Nana-Sinkam, M.D., associate vice president for clinical and translational research at VCU Health System 

As part of that, VCU experts are also working to educate people on the drug-approval process, scientific research on how effective new treatments are and other topics to counter misinformation. 

“We need to prove to these communities that we are, in fact, trying to serve them and be good stewards of their care,” Nana-Sinkam said. 

Recruitment also requires moving beyond traditional methods. “The older model of putting up a sign and waiting for patients is not effective anymore,” Nana-Sinkam said. “We have to meet patients where they are — in their communities, physically and mentally.” 

Ensuring patients can join a clinical trial no matter where they live  

Massey also works to ensure access across the cities, counties and towns it serves in Virginia. Through its NCI Community Oncology Research Program, the center partners with community sites statewide so that patients can participate in trials closer to home. 

“We use our NCORP network to extend research opportunities to patients across the state so that they don’t always have to come to downtown Richmond for clinical trial options,” said Michelle Liendo, MSHI, director of clinical research operations and management.

Massey on the Move is a community outreach program that provides members of the public access to cancer screening, educational resources about cancer prevention as well as information about clinical trials. (Phillip Newsome, VCU Massey Comprehensive Cancer Center)

Diversity in participation is essential. “Different diseases tend to be more common and more deadly in different patient populations,” Moeller said. “It’s really important that we try new medications in those populations.” 

VCU Health’s network includes hospitals in South Hill and Tappahannock, where the system is working to bring more rural patients into trials. Strides are being made in these regions, as the first-ever cancer clinical trial launched at VCU Health Tappahannock Hospital in late 2025. 

The groundwork for clinical trial recruitment is often laid months – even years – in advance by building lasting relationships with community members. The Massey on the Move mobile unit is one of those outreach methods. It provides cancer screening, prevention education and information about clinical trials.  

“What Massey does is really a perfect model for engaging the community and ensuring more diverse participation,” Nana-Sinkam said. 

Given the population that Massey serves, when designing trials, there is an intentional focus to reduce access barriers for populations in need. “We’re focusing on community-informed trial designs to make sure access for all individuals is built-in from the start,” Liendo said.  

Impact clinical trials have on medicine 

VCU and VCU Health’s involvement has contributed to major medical advances, including a gene therapy trial to treat sickle cell disease. VCU Health’s first patient to receive the therapy is doing well, and more patients are in the pipeline. 

“That’s probably one of the biggest success stories,” Nana-Sinkam said. “We’ve gone from a disease that is so devastating and results in multiple hospitalizations and even death, to one that, with proper therapy, could be either cured or managed like a chronic disease.” 

Other breakthroughs include treatment of cystic fibrosis, where patients now live decades longer than in the past, and cancer immunotherapy, which has changed outcomes for patients with previously deadly cancers.  

“Clinical trials have truly changed the course of certain diseases,” Nana-Sinkam said. 

Massey serves as the lead hub for the Vanguard Study, which is investigating a blood test for early detection of multiple cancer types and aims to enroll about 2,000 Virginians between the ages of 45 to 75 since it launched in July 2025. 

Maher said Massey leads hundreds of clinical trials each year. These have, over time, set entirely new standards of care for cancer treatment, and even improved related areas such as early detection, survivorship, palliative care and cosmesis after radiation and surgery.  

“We’re writing the standard of care for the country across many different cancer-related issues," she said. 

Clinical trial FAQ: Patient responsibilities and costs 

Why should I join a clinical trial? 

If you participate in a clinical trial, you will get access to cutting-edge treatments before they are available to the rest of the country or the world. Your care will be closely supervised by a specialized team of medical professionals and researchers who are experts on the disease you are living with. You’ll also be contributing to scientific discoveries that can help other patients in the future.  

What happens during a clinical trial? 

Joining a clinical trial means more than just taking a new medication. You may have extra doctor visits, tests or imaging compared to your usual care. Everything you’ll need to do will be clearly explained in the consent form before you decide to participate. 

What is a placebo? What happens if I get sicker on a placebo?  

A placebo looks like a real medication but doesn’t have any active ingredients. Researchers sometimes use placebos to see if a new treatment really works, because some conditions can improve on their own. Most cancer trials don’t use placebo, since using them would be below the normal standard of care for the disease. 

If you’re on a placebo and your health gets worse, you won’t be left untreated. Clinical trials always meet the standard of care, and if your condition worsens, the team will step in. You may be taken off the study treatment and given the care you need. 

What happens if my medical condition gets worse?  

Your safety comes first. If your condition gets worse, the clinical research team will review your situation and make sure you get the right care. You might be removed from the study treatment, but you’ll never receive less than the best treatment currently available.  

Will a clinical trial cost me anything?  

No, you won’t pay for the drug, lab work or procedures that are part of the trial. Sometimes routine care, like regular checkups, may be billed to your insurance, but most research centers, including VCU, have financial coordinators and social workers who can help reduce any financial burden. 

Why is VCU Health becoming a destination for clinical research? Learn more about our researchers and academic health system.

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