Q&A: COVID-19 impact on GI, hepatology practices
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With the rise of the novel coronavirus in the United States, it is important for hepatologists and gastroenterologists to know how other practices are dealing with the impact of COVID-19. With nationwide shutdowns, medical institutions and practices are finding difficulties in seeing patients and researching drugs.
Healio Gastroenterology and Liver Disease spoke with Stephen A. Harrison, MD, medical director of clinical research at Pinnacle Clinical Research in San Antonio and president of Summit Clinical Research, about how COVID-19 affects patient clinical care, research, best practices and his advice to future medical professionals on how to handle a pandemic. – by Erin T. Welsh
Healio: What impact has the COVID-19 pandemic had on your patient population, clinical care and research?
Harrison: Most ambulatory surgery centers are completely shut down (at least the practices I am aware of, to include my own), so no routine endoscopies are being performed and this has had a major impact on our GI practice. The challenge is that there’s no clear end in sight. There’s debate and there’s conjecture, but nothing firm, so that’s probably the biggest fear. This is an unprecedented time. When do you bring people back? When is it safe for patients to come in? How much longer can you go on before you can't pay the rent and can’t pay the bills? It’s a major challenge.
On the hepatology clinic front, up until about a week ago patients were still coming in, but now, most people are opting to remain sheltered at home. We’re using telemedicine with those patients just to be able to continue to provide some oversight of their care.
In research, we’ve seen an entire paradigm shift. What we’re trying to do is work with each sponsor to create the must have safety checks; the safety checks that are absolutely necessary to allow for continued delivery of investigational product. Each sponsor is a little bit different in how we deal with drug delivery. But despite that, we’re putting plans in place to deal with each of those unique situations. If a patient does not want to come in or can’t come in, for whatever reason to the clinic, can we send home health agencies out there? Can we send phlebotomy teams out to the house in that situation? It’s better if we can actually get the data analyzed centrally. If we can send a phlebotomist in, a home health agency in, with the kits from the sponsor, collect the blood, ship it to the sponsor’s central laboratory, that’s the best. In addition, there are different ways to deliver investigational product to the patient: it can come to our site and then we can package it and ship it to the patient, or it can come straight from the sponsor to the patient (as per sponsor guidance). We’re still trying to work through what’s the best way to do that, given each particular situation, but those are the kind of immediate challenges that that we’re faced with given this unique and precedented time with COVID-19.
Healio: How do you anticipate this will impact gastroenterology, hepatology and research going forward?
Harrison: We are seeing delays in clinical trial enrollment – for instance, my site being put on hold to new screens and to randomizations for right now. While there are some sites that are still open, a lot of them are closed. Even the private sites that are open are working with skeleton bare bones staff to keep people on study drug and ensure each patient is safe.
For new companies wanting to start clinical trials, those are going to be put off for a while. Likely 2-3 months in my estimation. For those on study that are enrolling, enrollment will stall out or slow significantly for a while. How long? It is hard to say. Likely weeks to a couple of months.
What about the people who are in screening who haven’t randomized yet? At Pinnacle, we’re still moving those people through where we’re able to. Maybe they need liver chemistry stability checks, MRIs or liver biopsies. We’re still having those people come in if they’re able or willing. For those people who need MRIs, we’re letting them get their MRIs if the MRI center is open, the same thing with liver biopsies. We’ll have them done if they’re open. At least in San Antonio, MRIs and our radiologists are still open- for now. I would say, across the country, it’s really variable as to who’s open or not.
Some patients don’t want to come in and, in those situations, the sponsors have allowed an extension of the screening window. We’re able to put a pause on it, delay it anywhere from 4 to an additional 8 weeks of screening. Now if they’re coming up on a hard endpoint, then we’re trying to get those done as best we can. We don’t want people off study drug, so we’re working with the sponsors to keep them on an extended dose of study medication until such time that that follow-up liver biopsy can be done.
These are still probably going to be deviations from protocol, but again, those are accepted in the current COVID-19 situation, as long as we can provide safe oversight of our patients during this time while they remain on investigational product.
My guess is with COVID-19 and all the research that’s trying to be run through the FDA right now, that may put other approvals and FDA guidance on hold a little bit as well. Data analysis can still go on, right? Statisticians still can work from home. So, there will be likely some companies that will report data in this intervening period, because they had already collected it and they were just doing data cleaning and having it analyzed. We may still hear reports of data coming out, but their subsequent development plans may be delayed because they can’t get started right away because of the COVID-19 pandemic.
Healio: What would you want to say to other HCPs or the next generation of HCPs?
Harrison: Just be aware of what's happening in the world. In this era of social media, word spreads very quickly. We had time to be better prepared, to have testing kits available and that sort of thing. We live in the great United States, right? Surely, we’re protected or we’re well prepared. It turns out, we aren’t any more protected than any of the other people and we weren’t prepared. So, lesson learned, hindsight 2020, we’re all kind of doing the things we need to do now, being good stewards of what we’ve been given. But we can learn a lot from our patients. Our patients are sometimes the first to say, I don't know, I'm concerned, should I come in? Is it better if we just talk over the phone or through FaceTime or telehealth so I’ve really learned a lot from my patients. We always think about being the teacher to our patients, but if we listen to them, we can learn a lot. Pay attention to your surroundings, listen to your patients and you never can be too prepared for this. We’ll get through it. We have resiliency like you wouldn’t believe, but we should learn from this and be prepared for the next one because to think that another one is not coming that could be as deadly or more deadly than this is foolish.
Disclosures: Harrison reports consulting for 3v Bio, Akero, Altimmune, Axcella, Blade Therapeutics, Chronic Liver Disease Foundation, Cirius, CiVi Biopharma, Contravir, Corcept, Cymabay, Echosens, Foresite, Galmed, Genfit, Gilead, Hightide, HistoIndex, Innovate, Intercept, Madrigal, Medpace, Metacrine, NGM Bio, Novartis, Novo Nordisk, Perspectum, Poxel, Prometic and Viking.