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Healthy Conversations brings together leaders and innovators in health care to talk about the biggest issues facing patients and providers today. Every month, we explore new topics to help uncover the clinical insights and emerging technologies transforming health care in real time.
DR. OWEN GARRICK
As we have a more aware patient population who begins to ask, "Are you sure that this drug works in a population that reflects me?" And you also have this push from clinicians, because we'll begin to look at the data much more strategically to say, "All right, does this data suggest the drug works in the population that I treat every day?"
DR. DANIEL KRAFT
Welcome to Healthy Conversations, an original podcast from CVS Health. I'm Dr. Daniel Kraft, and today I'm in Healthy Conversations with Dr. Owen Garrick. He's the Chief Medical Officer for Clinical Trial Services at CVS Health. We all know the traditional models of conducting trials in large academic centers or dedicated research clinics are often challenging for recruitment, especially when it comes to achieving a diversity of participants. How is the approach of CVS Health's new Clinical Trial Services unit different?
DR. OWEN GARRICK
We really want to make clinical trials part of a patient's everyday life, so you can come into a brick and mortar convenient community-based location, it's a very convenient small footprint. You can't get lost even if you tried to within a CVS store. You can participate digitally or electronically. You can have a home visit. So we really do have what we call an, "Omnichannel approach." And you talked about this notion around, or lack of, diversity in clinical trials, and a big component of that is increasing the trustworthiness of those that are conducting the research. And there, we are really leveraging the trusted relationship CVS has already in the community.
DR. DANIEL KRAFT
The pandemic did accelerate virtual clinical trials. How have you seen trials emerge and change, even in the three years since the pandemic hit us?
DR. OWEN GARRICK
That notion of not having to go to a centralized inconvenient location has really just spread throughout the industry. Now, one thing that hasn't exactly kept pace was the FDA and other entities being fundamentally comfortable with this decentralized approach, where we have seen much more adoption of that. Patients and research participants have, for a long time, wanted to decrease the burden of participating, and I think we had this confluence of the pandemic, staying at home, combined with the need and interest in continuing to develop new therapies, made entities, from the regulatory bodies to patients, be open to doing trials much differently than we've done in the past.
DR. DANIEL KRAFT
Yeah, 100%. My own personal experience, right before the vaccine, was available to the public. I developed Covid and I got a note on Facebook saying, "Hey, do you know someone who might have been recently diagnosed with Covid? Would you like to be part of a clinical trial?" And I clicked the yes button, 10 minutes later, had a phone call with the UW researcher, and the next day, FedExed out to me Fluvoxamine, a generic drug, and it came with a connected blood pressure cuff that they sent and an app, and I was a participant in a trial 24 hours after I signed up. Speaking reaching folks, 5% or less of patients actually participate in any form of clinical trial. What are the usual barriers to getting a broader set of participants? How's location and barrier, and what are some of the other ones?
DR. OWEN GARRICK
You might see a greater percentage of cancer patients participating than a chronic condition like hypertension, which isn't immediately life-threatening in most cases. But on average, we're talking low single digits in terms of individuals that could participate participating. So in terms of barriers, the most significant one is just knowing that you can participate. So knowing that a trial actually exists, and then similar to your experience, having a convenient way of participating. So as an example, you might have to get a blood draw. Most of us can't draw our own blood, but we can probably do finger sticks, but if we need a little bit more volume than that, we might have to either have someone come visit us or go to a convenient location for that.
The other things are, how long do I have to do this for? In your case, I imagine Covid anti-infectious study, we're talking days, maybe weeks, versus months and maybe years in various studies. A lot of us as researchers say, "Well, I have someone here. I want to study eight other things while I have him or her." But let's reduce the complexity, the time to participate, what we call the, "Research burden." You'll be more inclined to say, "Okay, I can do this." The other thing is, one of the beauties of how we've set up our research sites is that we're open on weekends, beyond the traditional 9:00 to 5:00. We should all be shocked at how uncommon that is.
DR. DANIEL KRAFT
Right. You want the easy button. You're already asking a lot of patients, sometimes with acute or chronic diseases, a lot of other challenges, you want to make it low friction when it's often not the case. As I mentioned, I discovered a trial because it got pushed to me. Is it now possible to identify you on a particular statin? There's a trial open that matches patients with you and your comorbidities that's available, and then via a push and you can opt in, let's say through your CVS Health app?
DR. OWEN GARRICK
Correct. And you referred to trial inclusion and exclusion criteria. So if we're studying a type two diabetes medication, one of the inclusion criterias would be you have type two diabetes. Now, as you know, there'll be drugs that might treat hypertension as well as diabetes. You could have some combination medications, so medicines that treat more than one condition. So in that case, a data science group combination with our clinicians can come up with algorithms that identify the patients that would qualify for a particular study, and then we have the ability to reach out to them by text or email or hard copy.
DR. DANIEL KRAFT
I look forward to being a data donor, as I like to call it. One challenge in traditional healthcare has been that many trials are not made up of a diverse population. We based a lot of our guidelines on Framingham data from a pretty narrow subset of Western Massachusetts. And then we know that folks of different ethnicities and age, gender, weight, pharmacogenomics, et cetera, are big, big factors. So can you let us know the value of diversifying the patient mix?
DR. OWEN GARRICK
We can't study all 300, 400 million Americans, so we study a small group, thus you can extrapolate or extend the results from a study of 5,000, 10,000 people to five, 10 million. That small group has to reflect the larger population, and historically, there has just been less diverse participation in studies. And so, from a medical perspective, the real issue is that you see differential response to the same drug therapy. That's the importance of having a diverse participation in a study. You can ensure that the drugs work effectively or you might have to tweak the dosage.
DR. DANIEL KRAFT
When you're picking a hypertensive regimen for an African-American versus Caucasian versus Asian, there might be very interesting things that would help us tweak the selection. Any favorite examples of how some of those trials with better inclusion can help drive better clinical decision making?
DR. OWEN GARRICK
I'll take a simple one. When I have a headache, I take Acetaminophen. I don't take Ibuprofen or Aspirin because it just doesn't work as well. Now, those are low-cost drugs. You might have a different choice in terms of what works for you. I wouldn't quite call that precision medicine, but it is certainly a way to better segment the population, so understanding what has, one, worked better for me, and then two, if we can do this prospectively, so if there are certain biomarkers that we have. If you look at Herceptin, that drug that targeted the HER receptor in breast cancer, that impacted maybe 20% or so of breast cancers, but it worked for that form of breast cancer and not others. So that is a really early success of this broader notion we might call precision medicine.
DR. DANIEL KRAFT
To that point, and I'm an oncologist, if we'd just run the trial on all breast cancer patients, Herceptin may have failed, but you need to identify those who are HER-2 positive, and then they have an amazing response. We're roughly at a $200, $300 full genome, we're getting the access to the microbiome, the proteome, the Sociome, this idea of the digital twin being able to really predict what might be optimal for an individual. Where might you think your clinical trial work could take us into the future of practice?
DR. OWEN GARRICK
The risk is, if we don't solve this current notion and issue around lack of diversity in clinical trials, as we get to precision medicine, we're only going to exacerbate some of that disparity in health inequity. We're only going to see more of a chasm. If we aren't evaluating early on individuals from different cultures who might have higher propensity of certain biomarkers that could trigger certain disease, we're not developing therapies that target those biomarkers or receptors. So you would then have this fantastic science in terms of very precise medicine that works for this group of individual, but you would've missed out on an entire group.
As you mentioned, that Herceptin case with the HER-2 positive biomarker, that only impacts roughly 20%. You still need to develop therapies for the rest of the 80% of the population. And you can see something very similar if people of color or different cultures aren't participating in that early genomic analysis. We run the risk of exacerbating health disparities when, over time, we'll be able to identify, as you've mentioned, an entire genome sequence for $200. And then, if we develop medicines where we can actually do something in terms of increased risk for a particular disease, one leaves out large amounts of the US and the world. And overall, I think we'll not just impact health outcomes for those individuals, but tend to increase cost broadly.
DR. DANIEL KRAFT
There is this opening of the gate of all sorts of diversity. The All Of Us trial from the NIH, a million Americans donating everything from wearable data to their clinical records to their genome. There's even a crowdsourcing platform called stuffthatworks.health, where you can see from, now millions of people, what's working and not working. Do you think that the clinicians of today and the future will learn how to integrate that into their workflow?
DR. OWEN GARRICK
I will hope so. Quick plug, CVS Health has participated in recruitment for the All Of Us study, and part of the reason that we were interested in supporting the program is that we have a very diverse patient population who then might consider being a data donor, which then leads to potential development of these therapies that could then impact that diverse community. As we have a more aware patient population who begins to ask, "Are you sure that this drug works in a population that reflects me?" You also have this push from clinicians, because we'll begin to look at the data much more strategically to say, "All right, does this data suggest the drug works in the population that I treat every day?"
DR. DANIEL KRAFT
100%. So you were brave enough to start Clinical Trial Services in the midst of a pandemic, in May of 2021. I'm just curious whether the Covid-19 vaccines was a catalyst? And number two, what were some of the challenges of getting an effort going in such a challenging window?
DR. OWEN GARRICK
You're spot on. So CVS was actually involved with recruiting and identifying subjects for the Covid vaccine studies, and that got the management team and board really focused on this. Aetna is, as you know, a part of CVS, and within Aetna, there's a group called, "Healthagen," which did a fair amount of real-world evidence studies. Then CVS also owns a business called, "Coram," which does impart home infusions across the US, and part of that home infusion business had a visiting nurse business that provided Clinical Trial Services in the home. So there's this 10 plus year history of CVS being involved with clinical trials.
If we take the example of hypertension medication, it maybe takes three months or so to show some reduction in blood pressure, so you want participants to at least stick around for those first three months. But you also want to see the long-term impact. Does that blood pressure reduction stick over a 12-month period? So you want to make sure patients stay for the duration of a study. So if it's easy to participate over six, nine, 12-month period, you will continue to come back for those six, eight, nine, 12 months. And what we have seen is really good response from customers and patients to participate.
DR. DANIEL KRAFT
Let's zoom out to another level. Health is social, it's community-centric, but you can also think about a community-centric model, as you described, for clinical trials. What differences might clinicians and patients experience from that kind of model?
DR. OWEN GARRICK
Immediately you know an entity like CVS Health because you go for part of your healthcare, whether that's retail prescriptions or specialty prescriptions or over-the-counter meds or MinuteClinic, say you have this relationship already that exists. As we introduce clinical trials and additional healthcare services, there's this built-in trust.
The other thing which is perhaps not as obvious is that, if you do this right, you begin to ask research questions that are relevant for the community, and you also begin to have them involved in developing those research questions and the research study. That would be the beauty of this model. So it's not just coming in and you participating in someone else's research, but you also helping us think through how do we combine, not just medical evaluation, but also the ability to access fruits and vegetables with a medical therapy to reduce hypertension or weight to improve health outcomes. Medicines and therapies is one part, one key part of that, but just one part of it.
DR. DANIEL KRAFT
You mentioned hypertension in there, and community, I think, could work at Cedars-Sinai with the barbershop model for African-American men that go into the barber once a month, you can check their blood pressure. And I can imagine, maybe in synergy with the CVS down the street, that could be a place for identifying and recruiting individuals to be clinical trial members.
DR. OWEN GARRICK
No question about it. And we hire staff as well, so it's the opportunity to engage and identify. Many folks got involved with research because they started as research coordinators and become part of the research enterprise.
DR. DANIEL KRAFT
What's the process for a trial sponsor to get involved with you on the sponsor side, and then how about on the patient side?
DR. OWEN GARRICK
On the sponsor side, we can go to CVSclinicaltrials.com. We have tons of customers that we work with, most, if not all of the top 20 biopharma companies. We participate in industry conferences. Hopefully we make it easy for you to reach out to us and actually do business with us. There's a contact link on that page. You've participated in the study and have had a great experience or a not so great experience, we want to hear from you so we can continue to improve our process.
DR. DANIEL KRAFT
And of course, being part of a trial, there's a big trust element involved. It summarizes the Tuskegee experiment, still has ramifications today. How do you think about the trust element and how do you communicate that?
DR. OWEN GARRICK
One of the things we think through as an organization is to make sure that our staff reflects the community. So if you come in, and whether you engage with our pharmacists or our nurse practitioners or our research coordinators, they are in fact members of the community. When you look at individuals as patients and people you know versus just customers, you begin to make sure they have a really positive and good clinical experience when you see your mom or your dad or your kids in them, and you begin to treat them just as such.
DR. DANIEL KRAFT
I'm also going to be talking on Healthy Conversations with Dr. Joseph Stavas from ProKidney, and I was wondering if you could tell me a bit about how CVS and how ProKidney are working together on trials and what you're evaluating.
DR. OWEN GARRICK
One of the things that I am looking forward to is their ability to and willingness to be innovative. We're going to assist them with their chronic kidney therapy, how we can do some very relatively complex services in our convenient locations to help them conduct a study. 20, 30 years ago, the notion of doing knee replacements in a surgery center was just foreign, and now, most of our orthopedic friends will do that pretty regularly.
DR. DANIEL KRAFT
Fantastic. So getting back to the meat and potatoes of trials, it's often big data. Can you share about the element of what you're doing with the data, and how having a richer data set helps the entire endeavor? And what insights are your data providing that are maybe surprising to you?
DR. OWEN GARRICK
In a research perspective, what it has allowed us to do is create some really new algorithms to identify subjects for very complex studies. So that's really the beauty of this trial, matching factor in certain drugs a patient might be on, but also certain diagnosis codes, where you can then really identify this precision recruitment. And then, the next step, is he or she really interested in participating?
DR. DANIEL KRAFT
So to wrap this up, we have a lot of healthcare providers listening, any caveats to make sure they get involved, not just for their own clinical issues, but for those of their patients?
DR. OWEN GARRICK
Maybe pick a therapeutic area, a chronic condition where a number of individuals could benefit from study participation, or a condition where we really want to advance therapies, and become a little bit more aware of trials that are happening in your area. From a patient perspective, continue to provide us feedback as to what works, especially for those that aren't participating. What would make it easy for you to participate? There is some reimbursement for expense in time, but for the most part you are volunteering, so we want to make that experience for you even easier.
DR. DANIEL KRAFT
Are you seeing any ways where CVS and your work is helping take the learnings from a trial and bringing that back to the patients with the actual issue?
DR. OWEN GARRICK
So as an example, we partnered with Uber and Uber Health to offer free rides for patients to study visits. And we did that because we asked patients what would make them more readily show up and participate. It's a relatively inexpensive thing, relative to the overall cost or a trial, and it ensures that retention over the long-term, and that more complete dataset. A simple thing like that, and we got, frankly, part of that idea from patients, because they're like, "This is something that would help me participate more."
DR. DANIEL KRAFT
Yeah, I love it. The Uberization of clinical trials, the transportation, even the lab draws.
DR. OWEN GARRICK
We don't do as good enough of a job as we should in thanking our patients for volunteering, in large part, their time for the advancement of science.
DR. DANIEL KRAFT
Yep. It's a team sport and we all need all folks rowing to improve clinical knowledge everywhere. So with that, I really want to thank you for joining us today. Our guest has been Dr. Owen Garrick, the Chief Medical Officer for Clinical Trial Services at CVS Health. We'll continue our conversation about clinical trials in the next episode of Healthy Conversations. I hope you'll join us then.
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