The Power & Promise of Clinical Trials

HAO & YANG SERVE AS KEY PHYSICAN-SCIENTISTS
IN CANCER TREATMENT DISCOVERY

Markey Cancer Center physician-scientists Zhonglin Hao, M.D., Ph.D., and Eddy Yang, M.D., Ph.D., are leading the way in translating lab discoveries into clinical trials that are improving patient care.

Hao is a medical oncologist and medical director of Markey’s Clinical Research Office, and Yang is a radiation oncologist and the chair of the UK College of Medicine’s Department of Radiation Medicine. Together, they have decades of experience leading clinical trials for a variety of cancer types.

During a recent roundtable discussion, Drs. Hao and Yang share the importance of clinical trials and how they play a significant role in changing how providers approach cancer care.

A lot of health systems now tout that they offer clinical trials as a selling point. Why is this and what sets Markey apart from other medical centers in this field?

Hao: The biggest motivation is that we’re seeing huge benefits from clinical trials. We think of a cure as a five-year survival rate, but new treatments that have come from clinical trials just in the past decade are now extending survival by years. Markey has a huge clinical trial portfolio from which our patients can potentially benefit. The Cancer Moonshot has also helped to increase investment in clinical trials, which is leading to even more progress.

Yang: Patients have access to the latest trials at Markey. Our NCI Comprehensive status is going to drive home the ability to perform even more trials, reach our community in a better way, and give our patients more access to treatments. Another piece that sets us apart is that we’re able to perform trials that come directly from our laboratory researchers. This homegrown research focuses on cancer types most prevalent in Kentucky.

How do you present the idea of a clinical trial to patients?

Yang: I always tell patients that clinical trials offer the latest and greatest new treatments. And it’s through a lot of work from the laboratory, testing and quality assurances that the clinical trial came about.

It depends on the type of trial, but usually we’re taking the current standard of care treatments and adding something new to it in hopes to improve the outcomes. I like to say that clinical trials could be the new standard of cancer care.

Hao: I ask them, “What’s your goal? Is it to get the standard of care? Or do you want to have extra miles?” If it’s the latter, we can offer something beyond the standard of care. It’s also an important reminder that today’s current clinical care came from yesterday’s clinical trial.

There’s some inherent mistrust between some populations and the medical/research community. How do you address that?

Yang: I think the important piece is to ensure that there is trust between the patient and the physician. And then from there, really explaining and listening. First is to educate them, in terms of the trial design and what exactly we’re doing to give them the best chance for a cure. And then from there, making sure that I understand what their concerns are for not participating so we can address those issues.

How important is it to ensure that clinical trials reflect diversity?

Yang: You need a diverse population of participants to really know that a clinical trial is successful. You could have a very high-impact trial with great results, but if the patient population is 90% Caucasian, the results might not be applicable to other ethnicities and races. This is because many treatments are based off biology, and there are other social and environmental factors that come into play.

“Our NCI Comprehensive status is going to drive home the ability to perform even more trials … and give our patients more access to treatments.”

Eddy Yang, M.D., Ph.D.

Hao: Diversity also includes age, which can be quite a barrier. A lot of providers are hesitant to enroll patients after the age of 80. One of my research projects is focused on how age impacts patient care. We looked at outcomes for 3,000 non-small cell lung cancer patients over 80. As suspected, a majority did not get any treatment. But those that did got just as good a benefit as younger people. If they are healthy enough to participate in a trial, I tell my patients over 80 “We’re going to let you try.” We have spent so much time developing wonderful trials and drugs. Everyone who could benefit from them should get that opportunity.

How has clinical research changed during your career?

Hao: I tell my patients that this is the era of precision medicine. In the past, we’d test treatments on many different cancer types and those that would show benefit in early phases would be advanced to later stage trials. But today, because of genomic testing, we can now pinpoint the patients more likely to benefit from a trial. Because the selection process is more efficient, there’s a better chance for the trial to be successful. In fact, it is now common for patients to see benefits in phase one (early) trials.

Yang: I feel that trials are much more complex, but in a way that we can gather more information and learn more from every patient that participates. Even if the trial is not successful, we learn what makes that drug work in some patients and not in others. I like to coin the term “B-B-B.” So it’s bench to bedside, but importantly, go back to the bench.

What is the moment you are proudest of?

Yang: To see my work be translated into a clinical trial for the first time after many years of benchwork in the lab. It takes some persistence to get there, and my mentors had said “Eddy, it’s going to take some time for anything to come about.” My proudest moment was when that trial was activated and IRB approved. I hadn’t even enrolled a patient yet, but it was about five years of work to get to that point.

Hao: I am the happiest when my own clinical trial is launched to test the hypothesis and see if the treatment can eventually help patients. Or after some time in research, I discovered that treatment outcomes can be improved without going through a clinical trial. For example, when you treat colon cancer patients in a specific sequence, you have an opportunity to improve their survival.

“Today, because of genomic testing, we can now pinpoint the patients more likely to benefit from a trial. In fact, it is now common for patients to see benefits in phase one (early) trials.”

Zhonglin Hao, M.D., Ph.D.

Yang: It’s rewarding anytime patients are benefitting from clinical trials and we can bring great news to them, especially when they’ve been through so much during their cancer journey. For me as a researcher, to be able to say to a patient that the treatment is working, and it’s from the work we did in the lab – because lab work can be very frustrating. But that one great moment wipes away all the frustrations.