What role do retail pharmacies have in research studies? In this episode of the Scope of Things, host Deborah Borfitz speaks with Ramita Tandon, Chief Clinical Trials Officer at Walgreens. Tandon discusses how retail pharmacies can play an important role in increasing access and retention in sponsor-lead drug development research. She also shares the specific approaches Walgreens is adopting in the US that have been gaining traction. Finally, she talks about why it is important to begin diversity and inclusion planning early in the drug development process and how it can allow researchers to think more holistically through the phases of clinical trials.
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What role do retail pharmacies have in research studies? In this episode of the Scope of Things, host Deborah Borfitz speaks with Ramita Tandon, Chief Clinical Trials Officer at Walgreens. Tandon discusses how retail pharmacies can play an important role in increasing access and retention in sponsor-lead drug development research. She also shares the specific approaches Walgreens is adopting in the US that have been gaining traction. Finally, she talks about why it is important to begin diversity and inclusion planning early in the drug development process and how it can allow researchers to think more holistically through the phases of clinical trials.
Scope of Things Links:
Clinical Research News
Scope Summit
Walgreens Links:
Walgreens
Hello and thanks for joining us for this month's edition of the Scope of Things, a no-nonsense look at the realities and enigmas of clinical research based on those closest to the action who aim for great and, if need be, are willing to shake things up. I'm Deborah Borffitz, senior Science Writer for Clinical Research News. In today's episode I'll be speaking with Ramita Tandon, chief Clinical Trials Officer, walgreens, who believes retail pharmacies can play an important role in increasing access and retention in sponsored lead drug development research. She'll be sharing some of the specific approaches her company is adopting in the US that have been gaining traction to study sponsors. Welcome to the show, ramita.
Speaker 1:Thank you, deb. Thank you for having me today. So happy you're here today. It is no secret that retail pharmacies are still trying to find their place in the clinical trial ecosystem, although, with a recent announcement by CBS that it is exiting the business, walgreens has taken the lead on this front and made clear it intends to stay the course. To get us started here, can you share with listeners why now is a particularly good time for pharmacies to get into this line of work at all?
Speaker 2:Yeah, it's a great question. As we think about pharmacies as a whole, we're all facing challenges such as rising competition, declining reimbursements for traditional dispensing services, which is creating a need for us to look at alternative revenue streams, and as we think about clinical trials, it provides another opportunity for pharmacies to generate additional income by offering services like patient recruitment, medication management, as we collect the data for trials and just go beyond our typical core operations within our pharmacy infrastructure. And so, for us, participating in clinical trials can also increase foot traffic into our pharmacies, particularly as patients that are within the communities that we serve. As they start to get educated and learn more about trials and want to get involved in trials. It brings these patients into the pharmacies for medication pickups, consultations and monitoring. So, for us, this represents another opportunity for pharmacies to engage the patients, provide personalized care and really carry forward the lasting relationships that have been built over decades with the pharmacists and the communities that they serve. So, for us, involvement in clinical trials can also position pharmacies as trusted healthcare providers, which is certainly an important aspect here at Walgreens, as we're looking to offer more basic healthcare services, and continues to demonstrate our commitment to advance medical knowledge, specifically in many of our medically underserved and rural areas across the nation and so adding clinical trials as part of our overall healthcare continuum that we're building here at Walgreens.
Speaker 2:We believe clinical trials is a holistic care option, particularly when standard of care is not a viable option for many patients that are trying to find ways to improve their health outcomes. So, again, for us it just reinforces our commitment to the communities that we serve that pharmacies are reputable healthcare destinations. We attract more patients and we're fostering loyalty among our existing customers, and so I would say, beyond this, the bigger picture of just getting the right care to our communities where they need it the most is very important to us and it's part of our overall journey that we're embarking on as we're moving into healthcare and we're seeing comfort levels increasing with this notion of visiting local pharmacies for basic healthcare needs, particularly when there's a critical need for us to look at ways to broaden the access to care as well as clinical trials, and so that clinical trials can be accurately representative of the US population. So, again, I think our local pharmacies provides an easy, accessible option for communities as they seek for healthcare services along with clinical trial services.
Speaker 1:Well for Walgreens. Was there any particular triggering event that kind of started you down this path beyond these kind of seemingly perfect market conditions? Was there any specific things that were happening?
Speaker 2:Yeah, it's a great question. During the COVID-19 pandemic it became clear it was not a one size fits all strategy for us as an organization. I mean, when everything was shut down, we rose to the challenge to respond to the nation's healthcare crisis and starting to deliver the vaccinations across the US and with pharmacies embedded into our local communities, we have the unique opportunity to reach people who needed assistance the most. And, as you think about clinical trials, the model itself is very antiquated and it's in crisis. The system level barriers that exist today in the clinical trial ecosystem oftentimes leads to disparities, and particularly during the COVID-19 pandemic, we saw that for the vaccinations. It again wasn't the same.
Speaker 2:The information and access wasn't distributed across the board, and so we, as pharmacies, had the opportunity to help overcome those barriers as we started to use our locations as welcome entry points to engage our communities, educate the communities about the right, the information about the vaccines, and then provide the empowerment for patients and consumers to feel comfortable that they had enough information to get shots in the arms.
Speaker 2:And that same principle applies to the clinical trial ecosystem, particularly as we know that less than 5% of this nation that participates in clinical trials and those that participate. 75% are white, and 20% of the drugs that are out there today have variation in responses across the ethnic groups, and so we're building on the lessons learned during the pandemic as we have built a clinical trial operating model that's patient-centric, that's inclusive, and for us, it's about ensuring that we're building the right highway into the communities that we serve, particularly those that have been traditionally left behind from the clinical trial ecosystem. So our goal is to make sure that clinical trials is inclusive for all the communities that we serve here at Walgreens, and so, again, it provides an opportunity to learn, to be educated and then feel empowered to be able to then, you know, sign up and participate in a clinical trial. And so, again, you know, we're looking to redefine the whole entire patient experience, as we, you know, broaden the access and convenience for patients to participate.
Speaker 1:Yeah, something novel has to be tried here. So it's because the old ways are certainly not working. The clinical trials business unit itself seems like a rather unique animal. It's inclusive of a system to match patients to trials using social determinants of health information and aggregated pharmacy and clinical records, as well as this just-in-time building of clinical trial centers in locations where study sponsors want to enroll participants. So let's start talking here about the technology piece, how the matching happens, and the experience for individuals flagged as candidates for a trial. How does that all work?
Speaker 2:Yeah, it's a great question and thanks for asking. You know, when we launched the business, june of last year, we were very judicious and intentional about the types of services that we wanted to provide to the industry and we, you know, we took a look at all the different assets and investments that we've made as an organization, particularly as we move into healthcare, you know, and as we made the investments in primary care, specialty and home health, we thought how do we ensure that, as we create this clinical trials model, we're able to tackle the issues around diversity, access and equity that we've seen that's plagued this ecosystem for a very long time? So, you know, what we've launched are three specific verticals, the first one being, as you mentioned, around the patient identification and acquisition process, and so the investments that we've made in technology allows us to canvas our patient population of, you know, more than a hundred million folks that visit our stores and pharmacies on a regular basis, and our technology allows us to not just identify the individual but also look at it from a race, ethnicity, geographic location or by zip code and other social determinants of health information that we might have on the patient, including any information that we might have from a front store perspective, as a consumer may be walking into a Walgreens and picking up merchandise, et cetera, and we're using that information, you know, with speed and precision as we match those patients to trials. You know, as our pharma partners, you know, knock on the doors of Walgreens and saying, look, we've got a clinical trial that we need help on. We need your help to find patients, particularly looking at diverse patient populations.
Speaker 2:We're in a very unique position because we're in communities that most have never had access to, and so our technology enables us to provide the insights of the patients, both the pharmacy records that we have, but also, through a partnership with Pluto Health, we have access to clinical records, and so we've made the investments on the back end to stitch together both the pharmacy as well as the clinical records to give us a holistic picture of the patient's journey. So, as you couple that with social determinants of health the race, gender, ethnicity again we wanna be more precise about matching patients to trials, rather than just sending out massive outreach campaigns to those patients to see if they're eligible or wanna participate. And so, once we're able to identify those patients through a very rigorous, compliant and regulatory framework that we've built, that surrounded this enterprise that we've created here at Walgreens. We have the ability to outreach to the selected patient populations through a number of channels, whether it's emailing, texting, using our call center infrastructure to call patients, or even snail mail, depending on the patient population, but also being very sensitive.
Speaker 2:Again, this is what we learned during COVID-19, making sure we're being culturally relevant in how we outreach to this patient populations the den um to see if they'd want to participate. We leverage our outreach channels run through a specific workflow that protects the patient's privacy as well as data privacy. We're able to leverage one of our outreach channels to provide culturally relevant invitations to patients to review the information and decide to then progress in the workflow. We've created the workflow that protects the patient privacy and protects the research integrity of the enterprise that we've created. Once the patients decide to opt in and want to participate, we have the ability to offer a flexible set of options by which a patient can participate in a clinical trial. I'm sure we can talk more about that next, but certainly our technology enables us to support the workflow from start to finish, any sense of how patients are responding to these opportunities.
Speaker 1:Have you got any feedback at this point?
Speaker 2:Yeah, it's been great. Certainly we've made outreach to over 2 million patients since we've kicked off this business. We've had tremendous uptake on patients opting in to learn more and then ultimately being recruited to participate in our trials, particularly in our minority patient populations. It's been a tremendous uptake. We're grateful to see the minimum patients coming in to want to learn more about the trial itself, or even Deb to understand what a clinical trial is all about?
Speaker 1:Right, it starts there, dana. Okay, I believe that the role of these clinical trial centers is broader than enrollment, at least theoretically. How many of these centers have popped up anyway, and where do they factor into the study process? For how long, I mean, do they exist one trial at a time or remain active as a study site more or less indefinitely?
Speaker 2:That's a great question, deb. We as an organization, as we're moving into healthcare, we have healthcare destination hubs that have been created across our ecosystem that are providing healthcare services like screening, diagnostic and phlebotomy services. We're leveraging our existing footprint and our existing healthcare destinations as we convert them as clinical trial centers. Certainly, we have to outfit them to ensure full compliance GCP, ich and we're protecting patient privacy as well as the research integrity of the enterprise we've created. Today we have about 15 clinical trial centers that have been spread across our nation. In part, it's to again serve as welcome entry points, at minimum for patients to come in to understand what a clinical trial is. Thank you for that.
Speaker 2:Believe it or not, for many of our communities that have never been invited to participate, those are the fundamental questions that are being asked of us, and when a patient comes to our centers, we've already embedded the clinical trial into our pharmacy workflow.
Speaker 2:So if you go in to pick up a prescription and if you're flagged as an eligible participant for one of the clinical trials we're entering, it gets flagged with our pharmacist and then the dialogue between the pharmacist and the patient then kicks off to be able to then talk about the actual clinical trial and see if there's interest in participating.
Speaker 2:So we've set up these centers so they become part of the workflow in our pharmacy infrastructure ecosystem, so that it becomes easy for the teams that are within the pharmacy ecosystem as well, as it makes it easy for a patient to be able to come in and learn about a clinical trial. And if they're interested, then certainly clinical trial services are being conducted within these clinical trial hubs that have been designated as such and we have a just-in-time approach. So, in other words, rather than just having them built out, we want to be very opportunistic and as our manufacturer partners come into our ecosystem and start to bring trials, we then have an opportunity to understand where those centers need to be set up and as they're set up, they're there to be able to support future clinical trials Very interesting.
Speaker 1:You know, I listened in on your LinkedIn live event a few weeks ago on diversity in clinical trials and I wanted to bring this up because I was struck by some of the comments that were made by a guest on the show, tony Young, founder and executive director of the Community Education Group. So I'll just give me a minute here because I'm going to get your thoughts on this. I mean, she was sharing that the hesitation of some African Americans to participate in trials wasn't necessarily that they had prior negative experiences with a healthcare system or clinical trial, but they had a bad experience with some sort of large system, possibly even the telephone company that was being inflexible. And she also suggested the need to move more upstream to create a what you call it 0.5 phase of studies. That involves educating students and future scientists and working with larger labs and sample repositories to, as you put it, bake in the notion of thinking about race, ethnicity and gender early on. So it has a domino effect across the entire drug development workflow.
Speaker 1:Tony also pointed, most interestingly to me, the potential impact of partnering with Dollar General to address access issues for would-be participants in rural areas who are already in those stores an average of two to five times a week Sound familiar, okay, so what's your take on all this? Any role for Walgreens and enacting these or other innovative ideas? Are you partnering with others to make these sorts of things happen at the same time?
Speaker 2:maybe, yeah, first of all, I'm glad you were able to join our LinkedIn live, so thanks for joining and listen. I think what Tony shared was, you know, her perspective was absolutely fascinating. I actually agree with the notion that starting to think about diversity planning, starting to think about being more inclusive, should be more upstream in the overall R&D process and, you know it can start in as early as you know the scientist you know working through, you know looking at ways that identifying the assets and looking at patient populations and segments and making sure we're being inclusive from a race, gender, ethnicity perspective. So I absolutely agree that we've got to be, you know, looking at this more upstream and the overall R&D process, and it does have an overall effect across then the entire drug development process, because then we start to think about this more holistically as we carry forward, you know, through the phases of the various clinical trial process. And so for us at Walgreens, you know we are doing a lot of work in this area. In fact, this is our why of why we, you know, launched the business. You know we want to tackle the issues around diversity, access and equity and looking at it from that lens Because, again, there are a lion's share of the communities that we serve at Walgreens, who one have never participated, never been invited, or, you know, especially during the COVID-19 pandemic, we learned firsthand there's a lot of mistrust, there's fear, there's misperceptions out there today about clinical trials, and so we believe that active community engagement and being in the communities is going to be such a pivotal part of, you know, tackling the issue around diversity in clinical trials.
Speaker 2:And certainly you know we're partnering with manufacturers, healthcare systems and others that want to come into the, you know, walgreens ecosystem and making sure that we're proactively providing those resources, whether it's educational resources, whether it's partnering with local communities to generate awareness about a particular disease, clinical trials. But ultimately our goal is to make sure that our patients, within the communities that we serve, are feeling informed and confident to make a decision, to participate in clinical trials, and I think that's a huge step for us to tackle the issues that Tony was talking about.
Speaker 1:Yeah, now back to Walgreens. Exactly how many? How much clinical trial business does Walgreens have under its belt at this point, and in what disease areas? What can you share at this point?
Speaker 2:Yeah, since we've launched, we have had discussions with nearly top 20 of the all 20 of the pharmaceutical companies, with strong support and across all the different services that we're offering today.
Speaker 2:Certainly, we've made some public announcements around our work with Prothina and Alzheimer's, with Renome and early cancer detection research respectively, and we've signed nearly 10 to 12 contracts and we're continuing to build on that as we have an active pipeline of support from the manufacturers to come into our ecosystem and leverage a number of our services. As we think about the disease areas, certainly we're supporting a number of COVID vaccine studies, cardiovascular outcome programs, alzheimer's, cancer screenings, diabetes. We've invited over 2 million patients that have been contacted as part of these efforts and we continue to go down this process. So, look, we're excited. We're excited to hear and the response that we're receiving about the role retail pharmacy can play and again, we've been very upfront. We're not here to replace the current existing provider patient relationship in the clinical trial ecosystem, but we want to be a support mechanism where we can offer accessibility and convenience for a lion's share of the communities that we serve here at Walgreens.
Speaker 1:And on that point, does Walgreens have ambitions to expand further into this business in terms of being a distribution point for investigational products or providing home-based services for some or all trial participants?
Speaker 2:That's a great question. Certainly we've been very again, like I mentioned earlier very intentional and judicious about the services that we've launched. For us, it's very important to make sure we have the right body of evidence that supports the value differentiation and certainly providing revenue streams for Walgreens. And today we're in the patient recruitment offering. We're bringing trials to patients, or what the industry calls decentralized clinical trials. We're focused on diversity initiatives and the other piece is real world evidence. We've spent a lot of investments around creating our real world evidence engine, which allows us to leverage the insights that we have on our patients and consumers in a very compliant and safe fashion to be able to provide those insights to the manufacturers as we look at designing better trials, better patient-centric protocols. So that's where we're in today and we're being very, again, judicious as we create that body of evidence to demonstrate the effectiveness and the value differentiation we can bring to the industry.
Speaker 1:Sounds like a smart strategy. Okay, I want to turn now to the Village MD primary care clinics that I know Walgreens has been establishing in some of its stores over the past few years, in this case, of course, to expand access to high quality and affordable health care. Is there any crossover between these locations and the stores serving as clinical trial centers? Are these totally separate efforts? I would think there's got to be some synergy there, but that helped me understand that.
Speaker 2:That's a great question. When we built out the clinical trials business, the idea was to leverage our entire enterprise-wide footprint, including the investments that we've made in primary care specialty and home health, and Village MD certainly is part of that solution set. And so you know, as we bring trials into our ecosystem, each of the trials and the requirements are very different and certainly where there is a need for us to leverage the Village MD ecosystem, we certainly will be able to do so. Our ultimate goal is to provide a flexible set of options to our patients because, again, as I mentioned during the COVID-19 pandemic, we learned it was not a one size fits all strategy. So, whether it's coming into our location and that could be our clinical trial centers, our Village MD centers, virtual by using home health solutions like our Acid or Care Centrics, or even a hybrid model, our goal again is to leverage all the investments, all of our Walgreens horsepower, to help support the clinical trial business and to be able to deliver trials into our communities.
Speaker 1:Now, surprisingly, pharmacists, despite being subject matter experts on drugs, haven't traditionally gotten involved in clinical trials. How do you prepare them to responsibly dive in so study sponsors can be assured that research integrity and patient safety are being protected? What are you doing?
Speaker 2:I know you're on it, but tell us more, that's a great question, deb, and I'm glad you asked this because, you know, since we've launched this business, compliance and protecting the research integrity of our enterprises most important to us, particularly as we bring trials into our ecosystem.
Speaker 2:And so, as it relates to the pharmacist, we have built a pharmacy training program that enables pharmacists number one, to go through, you know, understanding the ICH guidelines, the GCP training, and we use the training platforms that are out in the industry today that are being used by the traditional, you know, clinical trial sites that are out there today. We've brought a lot of that into our ecosystem. And one step further, we're also doing mock simulations with our pharmacists, so we actually have our staff that go into our locations that are our clinical trial hubs, where we actually go through mock training, and it allows pharmacists, while there may not be clinical trialists, but an opportunity to go through a clinical trial simulation, ask all the questions that they need to ask so that they feel comfortable and when we go live or when they go live, they know what to expect and how to manage. You know, the day-to-day of clinical trial activities, and so that is one way how we've ensured that pharmacists feel comfortable and have the education and training prior to getting involved in clinical trials.
Speaker 2:And they like the experience yeah look, many of our pharmacists are clinical pharmacies. They, you know, part of their training was to be able to provide patient care and, you know, part of Walgreens overall response, as we're providing healthcare services, is to remove some of the administrative aspects of dispensing and move towards, you know, closer to providing patient care. And so the feedback has been tremendous and the support has been tremendous because, again, as I mentioned earlier, clinical trials should be viewed as a care option and that is our North Star, and it doesn't matter in what provider setting. In our setting it's the pharmacy ecosystem, and so pharmacists are excited about providing another option to the patients that they serve, particularly if they've seen patients who've been using the current standard of care. It's not working and they're offering a novel, you know, diagnostic drug or device as an option to help improve their outcomes. So it's an exciting opportunity for them as well.
Speaker 1:These do sound like exciting days to be a pharmacist, or at least one employed at Walgreens. I know there's no shortage of interest and intrigue, as well as a few unknowns about the ultimate role that retail pharmacies will play in the clinical trial enterprise. So let's plan to stay in touch and talk more. For now, just let me say thank you for being here today and enlightening us on the promising possibilities.
Speaker 2:Thanks.
Speaker 1:Deb, appreciate it. Time. Yep appreciate yours. Anne is always. A big thank you to everyone out there for listening in. If you're not subscribed to this podcast yet, please consider going to Apple Podcasts and doing so right now, so you don't miss your monthly dose of news and perspectives. You'll be hard pressed to find anywhere else, and if you're up for it, I'd be so very grateful if you'd leave a rating and review on Apple Podcasts too. One final note, an important one If you like today's conversation. It is only a glimpse of what you can expect from the presenters and panelists we have on tap for CHI's Summit for Clinical Ops Executives Europe, aka Scope Europe. Please plan to join us October 17th and 18th in Barcelona, spain, and please be sure to use discount code SOT10 for a 10% discount off any current rate. For more information, visit scopesummitEuropecom. Bye for now.