A North Carolina woman traveled to MD Anderson Cancer Center in Texas for recommendations on her metastatic colon cancer, which had not responded to traditional treatment. Physicians there checked a database for clinical trials where she might access a promising yet experimental new drug.

They found a trial with an open slot – back home, at Novant Health.

Clinical trials seek to uncover whether potential new treatments for heart disease, stroke, cancer, and other illnesses are safe and effective. Trials can test new medicines or drug combinations, medical devices, surgeries or other therapies.

Dr. Franklin Chen wears a white coat and smiles.
Dr. Franklin Chen

Novant Health is a leader in clinical research. Nearly 1,500 North Carolinians are involved in more than 300 clinical trials at Novant Health facilities across the state. “Over the past several years, Novant Health has made a lot of investments into widening and broadening our clinical trial portfolio, including hiring more physician investigators,” says Dr. Franklin Chen, principal investigator of multiple clinical research trials at Novant Health Cancer Institute.

Along with contributing to scientific advancement, participants gain access to innovative treatment options and drugs not yet approved by the U.S. Food and Drug Administration (FDA). Clinical trials offer hope to patients whose previous treatments have not succeeded.

Novant Health physician investigators assess clinical trial opportunities across the United States and advise on which ones to pursue for Novant Health patients. “What we’re trying to do is bring into our communities the highest level of clinical trial access and early access to these drugs so our patients don’t have to travel,” Chen says. “They can spend their time being treated locally, close to friends and family. Clinical trials are part of our standard of care.”

Novant Health has more than 300 clinical trials in progress.

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World-class staff and facilities

Clinical trials are typically divided into three phases. Phase 1 is the initial research to see if a new drug or treatment is safe and has promise. Novant Health offers Phase 1 research trials in Charlotte and Winston-Salem through its developmental therapeutics program.

Clinical trial phases

Phase I: This early stage considers whether a drug or treatment is safe, along with any potential side effects. Up to 80 participants might join a Phase 1 trial, according to the National Institutes of Health.

Phase 2: Phase 2 trials continue to focus on safety and effectiveness. Up to 300 patients might take part in each trial.

Phase 3: During Phase 3, it’s time to test the treatment on a thousand people or more. Researchers compare the new drug to what’s already on the market to make sure it offers distinct benefits.

Phase 4: The research continues following a drug’s approval by the U.S. Food and Drug Administration. Investigators gather information on how the drug performs once it’s prescribed for patients.

Phase 1 is a delicate time in a medicine’s development, Chen said. “Somebody on this planet is going to be the very first human being to receive this drug. It has to be at a place with expertise, world-class facilities and world-class staff.”

Only a few institutions are generally allowed to participate in each Phase 1 trial. Novant Health has joined Memorial Sloan Kettering Cancer Center in New York, Dana-Farber Cancer Institute in Boston, and Yale Cancer Center in New Haven, Connecticut, in Phase 1 cancer trials. In some trials, Novant Health has administered the first dose to the first patient ever receiving that medication.

Once patients get a new drug orally or through an IV (known as infusion), they are closely monitored with blood draws to investigate how the drug is metabolized. This type of study, known as pharmacokinetics, helps determine what concentrations the study drug reached in the blood so that its dose and frequency can be calculated.

A Phase 1 trial may enroll only 10 to 15 patients across the country. The number increases during Phase 2 and Phase 3 trials as researchers continue to examine the treatment’s efficacy. Still, the size of trials can vary.

For common tumors such as breast cancer, “you may have a trial with hundreds if not thousands of patients taking drug A, compared to a similar number taking drug B,” Chen says. With a rare tumor, such as cancer in a muscle or soft tissue, the trial might be completed at Phase 2 with 30 patients who have done well.
The next step during Phase 3 is to prove statistically that the new drug is better than older drugs already available for the same illness. The most successful trials lead to FDA approval and potentially a new standard of care.

Accessing the treatments of tomorrow, today

Clinical trials test not only medications but advanced processes to fight disease. One study at Novant Health sounds like something a novelist might dream up. It looks at a cellular therapy called tumor-infiltrating lymphocytes to fight lung cancer.

Here's how it works. Inside a lung tumor, there are a small number of white cells called lymphocytes which "have something special about them. They have an ability to kill cancer," Chen explains. But because they're small in number compared to the size of the tumor, researchers believe the good cells need reinforcements to be effective.

That's where the clinical trial comes in. Physicians start by harvesting the tumor from the patient in the operating room. At a sterile processing center, a small number of lymphocytes are extracted from the tumor, then nurtured to grow into a huge amount of cells. Physicians put these supercharged lymphocytes back into the patient to attack the cancer following chemotherapy.

Whether examining drugs, device or surgeries, clinical trials have evolved through the years to enhance safety. Each clinical trial is led by a physician principal investigator with a team including research coordinators and data managers. They meticulously collect and analyze data on patients’ experiences.

Chen emphasizes that clinical trials allow us to access the drugs of tomorrow today. “All the drugs that we enjoy now came about through patients who have gone before and enrolled in clinical trials. Drugs we take for granted as FDA-approved came from the contributions of all these people. “

Intrigued? Look up Novant Health’s clinical trials here and talk with your physician to see if one is right for you.