Dr Howard Burris: Lessons Learned From a Crisis Could Assist Future of Clinical Trials

At the 2020 Community Oncology Conference, hosted by the Community Oncology Alliance (COA), Howard "Skip" Burris III, MD, FACP, FASCO, president, chief medical officer, and executive director of drug development for Sarah Cannon Research Institute, will discuss "The Now and Future of Clinical Trials in the Community Oncology Setting." The American Journal of Managed Care^® (AJMC^®) recently spoke with Burris, who is wrapping up his term as president of the American Society of Clinical Oncology (ASCO), about how the coronavirus disease 2019 (COVID-19) pandemic is affecting clinical trials as well as other aspects of the future of patient care in community oncology settings.

AJMC^®: Thank you for joining us today, Dr. Burris.

Burris: Thank you, and I look forward to speaking with you.

AJMC^®: At COA, you're talking about the present and future when it comes to clinical trials in community oncology. Given the current pandemic crisis, I feel like I should ask you to give an update about what is happening with clinical trials now and how you see them proceeding in the future.

Burris: So the clinical trial scenarios have really been quite varied. We have had a number of the large international pharmaceutical companies pause on their trials right now; their headquarters, some of the countries are involved with all in a situation where they feel like they can't adequately supervise the trials or be guaranteed about the data. On the other hand, I think a number of studies, particularly those that are working with our community sites, and are outside some of the major cities, are continuing to move forward. Our mantra at Sarah Cannon has been to stay the course, but to stay safe, and we're doing what we can to try to ensure both compliance as well as the patients feeling comfortable and safe and participating. But the fact is, there's a number of trials that have been halted, so accrual is going to be down and that'll slow up some drug development, and it's highlighted some of the areas where we need to think about for the future, so that we don't have any leaves like this, and the important work of getting some of these new therapies to market.

AJMC^®: You're also ending your term as ASCO president in June, and you're theme was “Unite and Conquer: Accelerating Progress Together.” There's been a lot of unity in healthcare workers coming together recently. How are you feeling about oncology coming together during this unprecedented crisis?

Burris: Yes, it's been a time for folks to reach out to each other, to interact. The social distancing has not been social isolation. I, in fact, feel like I've talked to more of my colleagues and we certainly have used more Facetime and various video conferencing. My theme, which you were so kind to bring up, on "Unite and Conquer” is really about bringing together the various stakeholders. I think it's always key that you have great nursing support, but also all the technicians, all the pharmacists. And then you think about the regulators, the pharma industry, the payers, all those individuals and all those companies that need to come together to accelerate drug development. It's clear that we're in a place if we're going to speed things up, and actually assess the new therapies and decide which ones are best to be given to our patients, we're going to need this sort of teamwork. During this pandemic, we've seen, really, most healthcare grind to a halt outside of emergency room care, COVID care, and then frankly, cancer care. And while it's varied in different parts of the countries in different parts of the world, cancer has never been an elective disease. It's not putting off a hip replacement, or putting off a valve replacement, or some of the other things that are very, very important healthcare issues. Cancer is a “here and now.” And while the situations of being urgent are few and far between, we certainly can't afford to put off cancer cure for any significant period of time.

AJMC^®: Do you have any concerns, since you mentioned financial issues, about the progress of payment reform in oncology in light of COVID-19? You know, there's supposed to be a transition toward the end of this year and next year in oncology care models. Are you concerned at all about that?

Burris: I'm always concerned about whether there is appropriate awareness and education about what cancer care entails. Certainly we're delivering therapies that have side effects. We often are in a scenario where the patient receiving the treatment has got their one chance for long-term remission or to have their disease be eradicated. So how we continue to support outpatient cancer care and continue to support those clinics begins to blend in a little bit more, as well as how we continue to reimburse for telemedicine, telehealth, which I think are key, but also continue to consider into our payment reform how we staff our clinics, so you've got sufficient technicians and phlebotomists, pharmacists, and most importantly, having great nursing care so that these patients are cared for appropriately. That's always a struggle. When you look at oncology payment reform, there are so many members of the oncology team that are involved, that simply looking at the physicians, E&M [evaluation and management] codes, and looking at the infusion of the drug is just a small part of the story.

AJMC^®: Are you hoping that some of the flexibilities that CMS has announced recently about telehealth continues in oncology going forward, especially maybe around clinical trials?

Burris: Yes, I think this has been a great opportunity to think about how we can better utilize telehealth. So many patients need to travel for clinical trials. Sometimes that's a car ride. Sometimes it's a plane flight, and sometimes those are intervening visits or simple labs and what I would call the well-baby check to make sure that they're doing okay. Our patients have certainly loved having the opportunity to do that by telehealth, telemedicine. But we need to really think about at what point in the patient's participation in a clinical trial can those visits be done remotely. I think that all enhance accrual, enable a broader group of patients to participate, [lessen] the socioeconomic burdens to travel. There all the other factors that go into that part of the equation so this is an unplanned—and certainly don't want to have it repeated—pilot experiment on telemedicine or telehealth. We really need to take this opportunity to learn from it. I will say the patients have liked it. The first few are a bit awkward, [with] the doctors, nurses, and patients getting used to it, but the rhythm has picked up within just a week or two. So [we’re] excited about how we can incorporate this going forward.

AJMC^®: Are there any particular clinical trials that you're excited about currently?

Burris: Well, there's a variety of clinical trials that I think are very interesting. Right now we've got a number of studies where we're trying to have the immunotherapies work in a broader group of patients. In general, the immunotherapies have been very well tolerated. Certain diseases, it's been really remarkable in terms of the improvements—lung cancer, melanoma, renal cell carcinoma—but we all know in practicing that there's too few breast cancer patients, ovarian cancer patients, prostate cancer patients, you could add on to the list, who have not benefited to the [same] degree from immunotherapy. And we're beginning to see some combinations in that regard. Other targets, other immune enhancers that can be given with the checkpoint inhibitors, look very, very promising. On the other end of the spectrum, too, we're seeing some amazing new drugs in the area of hormonal therapy for breast cancer and prostate cancer. We have had therapies in that disease setting but we understand better resistance mechanisms. And, too, the hormonal therapies, certainly far removed from some of the more exciting IV therapies, but a critical part of helping patients live much longer. And then lastly, I'll just mention, we're still seeing one step at a time in terms of these molecular alterations. So you could go from what we saw with the BRAF inhibitors or the melanoma mutations, we move on to some of the other stories. But KRAS, which is a such a common mutation, [was] always thought of as an undruggable target. Now we're seeing KRAS inhibitors entering the clinic. So, you know, pharma [and] biotech scientists have figured out a way to develop through chemistry molecules that can affect those mutations, and incorporating molecular profiling into our patients’ care is going to be critical.

AJMC^®: Is there anything else you want to say about what people can look forward to or that they'll hear in your presentation at COA later this week?

Burris: So the COA conference is always a fascinating conference because it really brings together the care of oncology patients, some of the business aspects, the scientific and clinical needs and all go into our community practices. It's clear that the majority of cancer care occurs in the community; over 80% is certainly happening in these types of practices. So having these thought leaders and administrative leaders coming together to discuss best practices is vital. We're going to hear more and more about how our practices need to be aligned and ready to go to participate in the next round of cellular therapy trials, how we need to have not just molecular profiling, but molecular tumor conferences as part of our everyday life. That's just going to be another facet to the tumor boards, which are so important to care. And then lastly, the infrastructure so that we can do clinical research in more and more practices. We need to take our trials to the patient, modernize the patient trial process. So we're reaching out to patients, instead of making them travel to us and go to a practice that's nearby, and much of that can be done electronically. Telehealth is just one example. But training, remote monitoring, electronic data captureat, all the electronic technological advances need to be brought out to our community practices so that not only more patients, but more physicians can participe.

AJMC^®: Well, thank you so much for joining us today. We really appreciate it, and we look forward to your presentation.

Burris: Thank you very much for your time. Appreciate it.