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Is Participating in a Clinical Trial Right for You?


Beth Janes

April 20, 2016
When most people hear the word melanoma, they think scary mole. But for one patient at Greater Baltimore Medical Center, malignant cancer caused fluid to collect in her abdomen — over a gallon a week.

Her doctors suggested she enroll in a clinical trial involving two new types of cancer drugs. One works to help the body’s own immune system fight cancer; the other, a targeted therapy, changes the way cancer cells behave.

The patient received the immunotherapy drug first. When it didn’t help, the crossover study design dictated that she begin the targeted therapy. The results were incredible.

“I didn’t recognize her; she looked so well,” says Paul Celano, M.D., Medical Director of the Sandra and Malcolm Berman Cancer Institute at GBMC.

That’s just one of many clinical trial successes at GBMC. The center, which has the most clinical trials of any community hospital in Baltimore, has 50 to 60 open trials at any time, most in the area of oncology and endocrinology.

Why such focus on research? It gives doctors options and patients hope.

“We have highly engaged physicians who consider participation in trials an essential part of how they care for patients,” says Michael Stein, Executive Director of Oncology Services at GBMC. “Trials bring academic, cutting-edge care to a community hospital, and that’s unique.”

Clinical trials 101

At GBMC, healthy people are rarely enrolled in trials. Instead, doctors suggest eligible patients enroll because they believe the treatment could potentially help. Or, patients seek out the center for a specific trial.

Either way, “a trial allows patients access to medicines they couldn’t otherwise get, whether because they aren’t yet FDA approved or aren’t indicated for their particular disease,” Dr. Celano says. “That’s part of giving them good care, and that’s the purpose of everything we do.”

GBMC trials typically compare drugs or analyze combinations of therapies to find what works best. Or they’re aimed at determining optimal dosage or protocols. Many also help researchers understand how cancer responds to new drugs or combinations to improve or further develop medicines. Regardless, every patient receives quality treatment.

“When the general population thinks of a trial, they think one group gets the drug, and one gets the placebo — but that’s not the case here,” says Connie Herbold, Clinical Trials Manager. “The control group is treated with whatever therapy is considered the standard.”

Why trials are essential

It’s through clinical trials that cancer treatment may soon evolve beyond traditional chemotherapy — known to leave patients weak and cause vomiting and hair loss — to those that are safer and more effective.

“Trials are essential to develop new life-improving, life-saving therapies. It gives patients a sense of satisfaction that they’re improving things for the future while helping themselves.”

Many current oncology trials involve the new treatment approaches the melanoma patient received.

Immunotherapy inhibits systems that cancer cells use to block your immune response. That unleashes your body’s disease-fighting army to attack and help stop the cancer.

Targeted therapies, on the other hand, work to stop how cancer cells repair their DNA or work to limit their blood supply so they can’t reproduce and instead die off.

“It’s a different way of treating cancer,” Dr. Celano says. “Many of these drugs are pills as opposed to (administered by) IV, and they tend to have fewer side effects.”

The decision to enroll in a trial

Although the treatments, like any drugs, do still have side effects, the unknown risks to patients tend to be minimal, Herbold says.

“A lot of the drugs we give are already FDA approved and the trials are about weighing this drug versus that one or combination therapies,” she says, adding that trials involving questions of safety are typically done at academic centers.

There’s also a lot of monitoring and oversight that further help mitigate potential risks. That may be another reason to consider enrolling in a trial.

“Patients get a more intense level of supportive care,” Stein says, explaining that dedicated follow-up nurses check in often and track patients’ progress, which has an added benefit: “It can engage the patient in their care more.”

On the other hand, sometimes the monitoring is a deterrent. “There are certain guidelines a patient has to promise to follow,” Herbold says. For example, one trial may require a quick blood draw once a week — not a hardship — while another involves getting blood draws before treatment, during treatment and at regular intervals afterward. If you can’t commit to being there the whole day, it might not be the right choice for you, she says. More than managing the logistics, however, also ask a lot of questions about the treatment itself, Dr. Celano advises. Understand what drugs you may get, the details on known side effects, what’s not known — and how the treatment differs from other therapies. That’s solid advice no matter what, he says.

Bottom line: Clinical trials advance science and help patients.

“Patients who participate in a clinical trial should know they are getting the best possible treatment and are being monitored in a rigorous way,” Dr. Celano says. “As an institution, we want to be recognized first for providing good patient care, but also doing good research, because good research is good patient care.”

—Beth Janes for Greater Baltimore Medical Center

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