Clinical trials point the way forward

November 03, 2016
Susan O'Brien
Dr. Susan M. O'Brien

Doctors at UCI Health are investigating an exciting new medication that uses a patient’s own immune system to attack leukemia cells.

Led by Dr. Susan O’Brien, one of the nation’s foremost leukemia experts and medical director of The Sue and Ralph Stern Center for Cancer Clinical Trials and Research, the study is being conducted at only six centers. UC Irvine Medical Center is the only site in Southern California to test this novel agent for chronic lymphocytic leukemia (CLL).

“As a National Cancer Institute-designated comprehensive cancer center, it’s one of our missions to conduct research,” says O’Brien, who was involved in developing four new CLL drugs approved by the Food and Drug Administration in the past three years. “It’s also our duty to foster improvements in the excellent care we deliver today by discovering even more effective treatments.”

The medication to treat CLL is one of many investigations underway at UC Irvine Health. It’s a Phase 1 clinical trial — the first of a three-part series of studies required for new drugs to be approved for treatment of cancer or other conditions. These early studies can often be described as “translational medicine.” That means promising studies in research laboratories are used or “translated” to enhance human health. This bench-tobedside approach accelerates the pace of new cancer treatments, O’Brien says.

Clincial trials point the way forward

Participating in a clinical trial may offer hope for patients with cancers that haven’t responded to the standard of care. If an investigational drug turns out to be effective, participants in the trial will have benefited from it long before it’s available to patients everywhere.

The FDA requires that clinical trials assess the risk of side effects. Patients enrolled in clinical trials receive close monitoring for side effects, as well as an assessment of their response by experts in their particular cancer.

“There have been a number of publications that report patients in clinical trials get excellent care because of the close monitoring,” O’Brien says.

Still, some patients fear they might be given a placebo if they participate in a clinical trial. It’s a common misconception, O’Brien says, noting that in cancer trials placebos are almost never used. In early trial phases, patients often receive an investigational drug along with the standard of care. Even in Phase 3 trials, where patients are randomly assigned to treatments, many designs give all patients the standard of care while some patients receive that care plus the new drug.

For example, a large randomized trial led by UCI Health Chao Family Comprehensive Cancer Center investigated the effectiveness of chemotherapy alone or chemotherapy plus bevacizumab for treatment of advanced cervical cancer. The results of the Phase 3 clinical trial, published in 2014 in The New England Journal of Medicine, showed significantly longer survival for those patients who received chemotherapy combined with the new drug and led to approval of the drug.

“It was a very important study that changed the practice of how we treat advanced cervical cancer,” O’Brien says.

UCI Health physicians often lead national clinical trials or initiate their own research projects. They conduct research into many types of cancers and lead clinical trials in Phases 1 through 3. O’Brien expects to launch a program next year to expand the scope of Phase 1 trials. The goal is to provide earlier access to new drugs for patients who’ve failed to respond to the standard therapies.

“We want to increase our clinical trials to provide our patients with the most promising options right here in Southern California,” she says.

Learn more about clinical trials at

— UCI Health Marketing & Communications
Featured in UCI Health Live Well Magazine Fall 2016


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