Lauren Harris, Wright Center’s hub research capacity administrator, interviews Antonio Abbate, M.D., Ph.D., the medical director of the Clinical Research Unit and an associate director at the Wright Center, and Joan Greer, R.N., nurse manager at the Clinical Research Unit at VCU Health.
Abbate and Greer answer your questions about clinical trials participation and what it’s like running clinical trials during a pandemic – in honor of Clinical Trials Day on May 20.
Full transcription below:
Lauren Harris (00:06):
Good afternoon. Thank you all for taking the time out of your day to come and speak with me this morning about clinical trials. As we all know, and the world may also know, that international clinical trials day is coming up on May the 20th. This is truly a time for us to thank our clinical research, trial coordinators, our nurses, our doctors, anyone who helps in getting clinical trials off the ground. International Clinical Trials will be celebrated across the world, not only from VCU and VCU Health, but across the globe. We will all be telling you thank you for your hard work and your dedication that you all put into this. Surrounding this, this day allows us also to broadcast some of the clinical trials that we have going on here at VCU and VCU Health. So today with me, I have. Dr. Antonio Abbate who is the director of the clinical research unit here at VCU Health and Joan Greer, who is the nurse manager on the North 8 floor for the Clinical Research Unit. Thank you guys.
Joan Greer (01:17):
Thank you for having us.
Yes, thank you all for taking the time. I know COIVD is claiming a lot of your attention, so thank you. Thank you. Thank you for today.
Dr. Antonio Abbate (01:29):
Yeah. Good morning, Lauren. It’s really a pleasure to be here with you today.
Thank you, Antonio. So I have some questions that I want to throw out there. You all can just answer back and forth. Tell me a little bit about your experience running clinical trials and how you came to do this.
Yeah, maybe I’ll start in. I’ve been involved in clinical research since I was a medical student. When I was studying medicine in Italy, in Rome. That’s where I’m from. I realized that much that I was learning was still to be discovered. And that lots of the things that we were doing for patients was still incompletely known. And there were no treatments for a lot of conditions, a lot of diseases. And that was just unsatisfying for me. And I thought, we need to do better. We need to be able to offer our patients more. And so that sparked the interest of doing research, both basic science research and clinical trials. What about you, Joni?
So I have been at the house system for 20 plus years now and I’ve worked in a variety of areas from cardiology. I didn’t have the pleasure of working with Dr. Abbate until clinical research, but that’s where I always think my home is. And then I went to the emergency department and then got into organizational education and found this little niche of clinical research on North 8. And as part of being a lifelong learner, I’m just absolutely fascinated with clinical research. And like Antonio said, it’s all about discovering what we don’t know yet and making or managing patients’ health better, helping with prevention as well as treatment and cure. And it really is a new discovery every day. I think the tagline for the health system, everybody kinda jokes about it, but in clinical research, it truly is ‘a new discovery every day.’ And it’s very exciting work that we do here. And I’m glad that COVID-19 has given us the opportunity to expand that down to Community Memorial Hospital in South Hill. So now they’re our partners and we are expanding more just from the downtown campus and moving it out to everywhere. So it truly is an exciting time for research.
Lauren, you know Joni and I are incredibly lucky to be working in the Clinical Research Unit. It’s just this, this wonderful unit that is centered around clinical research and clinical trials. It’s dedicated to patients that are involved in clinical research, has specialized nurses trained for this, a specialized space. But as she just mentioned, you know, clinical research doesn’t only happen in that unit, it happens everywhere, as you’re saying just now everywhere, all around the hospital, but also across the community. So we’re lucky to be there because we have like-minded people that are inquirers and discoverers and take challenges. But we love to go around and find patients that need our help. And in this specific time, our nurses from the Clinical Research Unit are particularly brave and hard-working and are tackling the challenge of bringing research at bedside in the rooms of patients that are affected by this coronavirus infection. And that’s really incredibly valuable. I’m so proud to be working with them.
Yes. I think some of the keywords that you all use were discovery and that’s exactly what it is that we do. When we look at clinical trials, we are discovering new ways to help people combat a particular illness, a particular cause. And I think that is something that when we think about clinical trials, I think that’s the part that sometimes we need to make sure that we communicate that to our participants that we are working with. That you could be the reason why we discover a new medication, you know, a new way of doing things. And I think that’s something that we have to make sure that we convey to the public. You all have both talked about being in the VCU health care system. Why is this a great place to participate in clinical trials?
Participating in a clinical trial, you can come in at different levels and sometimes one thing that being in a trial means that you are sick and you’re a patient and you need a treatment. And that is certainly true. But we also look for healthy volunteers in trials. We have what we call Phase One clinical trials where we are developing brand new treatments and we need healthy volunteers to determine how the drug is distributed in the body. And that’s very much needed. Sometimes we are doing development of drugs in Phase Two. Those are the earlier stage of development. Sometimes we’re getting closer to bringing those drugs to approval. That’s what we call Phase Three. And the patient’s more likely to derive a benefit that is the drug is closer to approval. At VCU Health we have a broad range of trials and we have an incredibly detailed and well-built oversight process. So for a trial to be activated, it has to be reviewed, approved, and monitored over time. So a patient signs up for a trial at VCU Health. But everywhere in the United States and most part of the world, the trial has to be vetted and it has to be a plan for guaranteeing that you as a human being are well cared for and monitored and your safety is always number one. So whenever there’s an opportunity for you to join a trial, you should strongly consider it. Because your care and your safety is number one priority for whoever is offering you that trial.
And Dr. Abbate, you just hit a key point. I think there is sometime a stigma behind joining clinical trials and that number one reason is safety. I think it is our duty when we bring potential participants into clinical trials that they know that their safety is number one, if at any point they have, there is clinical research coordinators, there’s doctors. There are a variety of individuals who are there to answer any of their questions that they may have.
I think it’s important to know that our nurses receive special training related to clinical research applications. So that we really understand the importance of protecting the participants that are in this study as well as have the competency to perform those clinical skills and tasks. Giving medications making sure we’re drawing labs, collecting samples properly, and communicating with the patient. What’s really great, I think here at VCU is that we have a dedicated clinical research unit. We have a dedicated team of nurses, so we really develop relationships with our patients. And you know, trust is number one. I feel like that that consistency and continuity is really helpful on North 8, but even as the nurses have gone throughout the hospital with the COVID-19 trials and going to multiple units to assist with administration of these clinical draws, we are just extending that trust and good faith to the units. The nurses, the team, the medical teams, the patients. We’re getting out there to let people know, you know, that we’re, we’re doing some great work here and we want them to be part of it.
I think that’s great. I think you all are doing a fabulous job. Dr. Abbate, you just, both of you actually touched on clinical trials. If I was a patient and I wanted to know where to find clinical trials, where would I even begin to look?
So the most of the times what happens is that if you are a patient admitted to the hospital, then you would be approached by a research coordinator or by a study investigator, a physician investigator, and they will be offered to you. This is because while there are venues to find studies, when you are affected by an illness, it’s difficult to go and navigate what you know, what opportunities there are for you. And I’ll tell you about those opportunities. But in most of the cases, patients that are at VCU Health, they don’t have to worry about going online. We have a system here that we evaluate every single patient that comes to the hospital. We look at them whether they could be a candidate for a clinical trial. And we approach them and we ask them whether they’d be interested in learning more about this trial. If the person is not able to communicate because they are unconscious, we approach their family members and we do this in a systematic way so everybody gets an opportunity. If you were at home and you were a healthy volunteer, one way to go on this, there’s a federal website is called clinicaltrials.gov that has a lot of information. Actually every study, virtually, has to be on that. It is again clinicaltrials.gov. Another web site is StudyFinder that you can Google and find and have all that information like location to find these studies. There’s also a website specific to VCU that you can put, just research.vcu.edu and you can find information about our clinical trials. Probably Lauren, you know more about this.
Look, I think you covered every area. I was counting. Thank you for that. Also, too, if you are interested as a participant and you want to be notified when clinical trials have been uploaded, we also have something called Research Match. Go onto Research Match, you can put your information in there and when studies become available we can ping you out and let you know what we also have too. So that’s the only thing you forgot Dr. Abbate.
Oh, that’s a wonderful opportunity. I think patients should take advantage of that for sure.
Lauren, sometimes patients bring up the question , will I be a guinea pig in a trial? And it almost hurts me when they bring this up and it’s because, you know, we’re certainly not doing this to take advantage of anybody or hurting anybody. That’s not why we’re here. We’re working hard. We are putting all our minds together, all our efforts together, developing very careful protocols, reviewing them carefully with the FDA, with the Institutional Review Board. The way I see it is we’re trying to offer our patients today what will be the treatment of tomorrow. And we’re really hoping to have better treatments than what we can offer today. We realize that not all of the treatments we’re offering are going to be successful. But we also realize that the treatments of today are not sufficient and we need to do better. We need to be trying better. And we promise that we continue to work really hard and if we continue pursue the most promising research and if we notice anything that doesn’t look right, we stop that research immediately. And we only pursued the research that appears to be safe. That’s really the promise that we have and we hold it every day and we review it costly as well.
I think that’s something that we want all of our potential participants and our current participants to hear that safety is number one. And we have your best interests at heart. There’s a trust and relationship-building that happens between us when you all conduct these trials. So what about the pandemic has really changed your experience, for example, with clinical trials and your patients?
I think the biggest thing that I touched on a little bit is about really building those relationships outside of North 8. Really taking clinical research to where the patient is. That’s kind of been a vision of clinical research at VCU and the health system for a while. And so I think, if you can look at some of the positives with COVID-19, I think that that’s been a big one for us is that we’ve been able to really expand our reach and build relationships. And now people say, ‘Oh, you know, there’s Joni, you know, the manager for — here’s Joyce, here’s Catherine, Kim, they’re all here to help us and to be successful in clinical research.’ And then, also I was so excited to go down to Community Memorial Hospital last week in South Hill and meet with the nursing leadership and train the bedside nurses on their very first clinical research trial because of COVID. It had opened the door for us to be able to really reach out that clinical research to help those patients and see the benefit. And so it’s just opened up doors and also helped us with more system processes, improvements with TeleTracking, which improves communication between all the coordinators and PIs, improve Cerner so that it’s easier to document. We even developed a video for how to administer the drug properly. Internet home page, lots of things that have really opened up opportunities that we were already planning, but it was just fast tracked because of that. So that’s positive. So that’s been a really good thing.
Lauren, if I can add, you know, one of the challenges that I had is that, outside of this pandemic or before this pandemic, I would be spending a lot more time at bedside, very close to my patient and usually also face to face with their family members. This is not happening right now. I’m spending a lot more time on the phone or on video calls. And one of the major stressors on the families is that they cannot be at bedside. They’re away and they’re getting information through the phone or through video calls and this is adding to their stress. Conducting research through this way, sending information by email, having them sign documents that are through the email, faxes, electronic signatures. It is adding additional complexity. I think the families and the patients are adapting to this because they understand the need, but it’s certainly lacking that human touch that we’re all accustomed to, that we all value very much. And we hope this pandemic goes away very soon because we all want to come back to being close to each other and hugging each other, shaking hands, and hopefully this will come back soon.
Yeah, well we definitely applaud you all for coming up with these creative measures. No one knew that COVID would take off the way that it has, but it’s forced us all to re-examine, you know, how we look not only at clinical trials, how we work with our patients but also just the bigger picture, you know, why am I in this profession? You know, it makes you ask those questions and I’m sure every day when you all go home, your families are happy to see you. But also the patients that you all are working with are extremely thankful for all of the services that you all are providing. And I will say that VCU and VCU Health, we’re on the cutting edge. I’m proud to be employed here and to be working with people like you all.
Yes, we are very proud. We are very proud and very happy to be offering our patients this opportunity. They can take on this opportunity. They can obviously also just take their standard of care. It’s only an option and opportunity, but we’re proud to be offering this.
Yes, thank you all. Hopefully we’ll be able to do more interactions like this to really start to talk about clinical trials and to really nail down some of people’s thought processes. How do I get involved? Once I am involved, what does it look like? I think these are the questions that some people have that they’re just scared to ask. So thank you all for helping bring more awareness to clinical trials and some of the work that you all do as we will be celebrating you all on May 20th. Thank you all.
Thank you so much, Lauren.