By Jim Ware / Sun Journal Correspondent
Posted Jun 26, 2019

While UNC and Duke are frequently in the news for medical research, cancer patients at CarolinaEast Medical Center can participate in national clinical trials without leaving New Bern.

One of those trials looks at treatment options for a precursor to breast cancer. The trial is named COMET, which stands for comparison of operative to monitoring and endocrine therapy for low-risk ductal carcinoma in situ (DCIS). The study enrolled 1,200 women at cancer centers across the United States, including at CarolinaEast.

Among other clinical trials underway at CarolinaEast are studies that involve lung cancer, colorectal cancer and prostate cancer, said Dr. Seth Miller, radiation oncologist and director of clinical trials.

“The goal is to open studies that are likely to be high-yield, high-accruing trials for patients in the disease types that are most representative,” Miller said. “We won’t necessarily open things that are more orphan-like. That’s probably going to remain at the university level. But big disease sites, opportunities where we can enroll a number of patients, are really what we’re focusing our initial efforts on.”

He said none of these studies are investigator-initiated trials at CarolinaEast’s level.

“We have the ability to open trials of that nature, for example if UNC or Duke had something really innovative that one of their investigators had initiated, but we focused on national, multi-institutional, largely randomized studies,” Miller said.

Patients participating in clinical trials receive at minimum of the standard care for their illness, he said.

“The investigative arm is looking at how to build upon the standard of care or the gold standard,” Miller said. “So, every patient in a trial is getting at the very least the gold standard and they’re potentially adding additional therapy that may even further improve outcomes or opportunities.”

Trials questions sometimes don’t show a benefit or, in retrospect, were more harmful than helpful to patients, he said.

Nearly all the physicians in the CarolinaEast cancer center are leading or co-principal investigators on a trial, Miller said. All investigators must meet regulatory and training guidelines.

“Lynn Harrison, our research coordinator, has been diligent on keeping us all in check, making sure we are both up to date on our training and renewed annually, so this is a huge effort on her part,” he said.

Physicians found the added paperwork valuable because it allows them to offer state-of-the-art care beyond the current standard because of clinical trial opportunities, Miller said.

“For each of the individual physicians, we’ve all had to personally say, ‘This is a really important part of how we take care of cancer patients in New Bern and the surrounding community,’” he said.

“The only way that we’re going to increase rates of cure, reduce toxicity and provide new treatment options for patients is through well-structured clinical research,” Miller said. “Being able to offer those trials at the local level provides not only additional opportunities close to home for patients, but it also sharpens the physicians.”

Miller is the principal investigator on three studies that are part of the CarolinaEast clinical trials portfolio as well as on a legacy trial for a former study opened at the hospital.

As director of clinical trials, Miller works closely with Harrison to look at future trial opportunities and assess the CarolinaEast trials portfolio and enrollment goals.

He also participates in monthly phone calls with the Southern Consortium of Oncology Research, a group based out of Winston-Salem that has funding from the National Cancer Institute to further structure clinical trials enrollment in the community.

Miller said doctors involved in clinical research do so on top of their expected full-time clinical obligations.

“I think that speaks to all of our commitments to adding a research component to what we can offer here locally because it’s not something that’s carved out of our schedules per se, but rather something we’re doing in addition to our commitment to taking good clinical care of the patients in the first place,” he said.

CarolinaEast’s commitment to build a comprehensive cancer center preceded Miller’s arrival in August 2015.

“The things that go into that require some robust commitments financially from the time and staffing standpoint that don’t necessarily return revenue dollars, if you will.,” he said.

“I think clinical trials is one component that the health system has said, ‘If we’re going to make this robust comprehensive cancer center a reality, we’re going to have to support that in time, effort and financially.’ And they’ve done that to the fullest that I think should so far to date.”