With 20-plus years of experience in clinical trials, Dr. Susan M. O’Brien leads the charge of translating basic research into actual treatment.
When O’Brien had to choose a direction for her medical career, it was easy: clinical trials.
“Even when I first entered medicine, this was an exciting field. Getting in on the ground level with clinical trials offers hope and opportunity to people who are doing poorly with standard care on existing drugs,” she says.
In January 2015, O’Brien joined UC Irvine Health as associate director for clinical services of the Chao Family Comprehensive Cancer Center and medical director of the Sue and Ralph Stern Center for Cancer Clinical Trials and Research. She brought a unique skill set to Orange County from the world-renowned MD Anderson Cancer Center in Houston.
A History in Basic Research
At MD Anderson, she not only had 20-plus years of experience in both running and overseeing clinical trials, she also was acutely aware of “hot new drugs” in the pharmaceutical industry’s anti-cancer pipeline. And as chair of an Institutional Review Board, she brought expertise and familiarity with the requirements of running clinical trials.
“UC Irvine Health has had a long, strong history in basic research,” O’Brien says. “Now some of those lab discoveries have reached the point that they need to proceed to the next step: clinical development. I’m here to serve as a liaison for the scientists.”
The $5-million 2014 Stern grant will greatly facilitate that. The essence of the Stern grant is to provide an engine to translate basic research—at which UC Irvine excels—into treatment.
Clinical trials are conducted in phases, each designed to test a separate research question. In Phase 1 trials, a new drug or treatment undergoes its “first in human” testing, where it is evaluated for safety, dosage and side effects. In Phase 2, the drug or treatment goes to a larger group to further test effectiveness and safety, and patients are monitored for progress. In Phase 3, the number of patients treated expands again and the new drug is compared with existing treatment in randomized trials. In Phase 4 trials, the drug is on the market and information is gathered on its effect in various populations and on side effects of long-term use.
“Previously, UC Irvine Health had difficulty mounting Phase 1 and 2 trials due to the complexity of safely running proof-of-concept and safety trials. This meant that some of our best discoveries and insights had to go elsewhere to be developed.”
Access to Developing Treatments
That’s exactly where Dr. O’Brien is focused. “I’d like to get the UC Irvine Health involved earlier in new drugs being explored,” she says. “Getting involved in clinical trials is great for patients who get access to drugs under development, and it’s rewarding for me personally to see patients respond to developing treatments. There are many steps in getting a drug ready for approval, I would like to streamline that process so that pharmaceutical companies start to automatically turn to the Chao Family Comprehensive Cancer Center for trials.”
One development undergoing trials is a device, not a drug. Diffuse Optical Spectroscopy & Imaging, or DOSI, is a handheld device developed at UC Irvine’s Beckman Laser Institute. DOSI is currently being tested as a way to monitor breast cancer tumors during chemotherapy and prior to surgery. With DOSI, patients can visit their doctor’s office to find out whether a tumor has shrunk enough to proceed to surgical removal. “Otherwise, these patients would need an expensive—and not always readily accessible—MRI,” O’Brien says.
Bench to Bedside
“Bench to bedside” is a phrase often used to describe the point in research when a potential drug leaves the researcher’s bench and begins to be tested with patients. O’Brien sees the process as more of a full circle than a one-way street.
“Once a drug goes into clinical trials, the research begins anew. The medical field now wants to know: Why does this drug work in 60 percent of the patients and not the other 40 percent? How can science make it more effective, perhaps by combining it with another drug or targeting a patient’s specific tumor? So research goes bedside to bench, too.”
And she is passionate about the importance of clinical trials.
Patients Advance Medicine
“There cannot be any new drugs without a clinical trial. And without patients willing to participate in clinical trials, we’re stuck with what we have. Drug development would halt without clinical trials. The benefits of new drugs can be blockbusters to patients who get access to developing drugs an average of 10 years before FDA approval. We need the patients for drug development, and patients—especially those not responding to existing treatments—need access to new drugs.”
Reflecting on her year at the Chao Family Comprehensive Cancer Center, she points proudly to the center’s recent five-year reaccreditation by the National Cancer Institute as a comprehensive cancer center, Orange County’s only such facility. “The accreditation renewal by NCI shows UC Irvine Health’s growing reputation.”