On Research Podcast – The Role of Pharmacy in Research

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1. The Role of Pharmacists in Clinical Trials (00:00:01) Discussion on the evolving role of pharmacists in clinical research and their potential in clinical trials.
2. Introduction to the Episode (00:00:19) Justin Osborne introduces the podcast and guest Adam Samson, discussing the focus on pharmacists in research.
3. Adam Samson’s Background (00:01:43) Adam shares his journey from dietitian to head of clinical delivery operations at Walgreens Clinical Trials.
4. Current Role of Pharmacists in Research (00:03:22) Adam explains how pharmacists contribute to clinical trials at various levels, including investigational product management.
5. Pharmacists in Independent Research Sites (00:05:22) Discussion on the involvement of pharmacists in independent research sites and their roles in clinical trials.
6. Benefits of Pharmacists in Research (00:06:25) Adam outlines the specific skills pharmacists bring to clinical research, emphasizing their clinical knowledge and patient interactions.
7. Complex Trial Designs and Pharmacists (00:07:39) The conversation touches on how pharmacists’ expertise is beneficial for increasingly complex clinical trial designs.
8. Decentralized Trials and Pharmacists (00:09:44) Adam discusses the impact of decentralized clinical trials on pharmacists’ roles and opportunities in research.
9. Patient Trust in Pharmacists (00:11:39) Exploration of the trust patients have in pharmacists and how it can enhance recruitment for clinical trials.
10. Integration of Pharmacy and Clinical Trials (00:12:47) Adam describes the collaborative approach between pharmacy teams and clinical researchers to ensure patient trust.
11. Hurdles in Pharmacy-Based Research (00:14:48) Discussion on the challenges pharmacists face in balancing clinical duties with research responsibilities.
12. Crawl, Walk, Run Approach (00:16:03) Adam explains the gradual approach Walgreens is taking to integrate pharmacists into clinical trials without overwhelming them.
13. Education and Awareness in Research (00:19:04) The importance of educating the public about clinical research and the role of pharmacies in this effort.
14. Community Engagement Initiatives (00:20:10) Adam discusses strategies for engaging communities and raising awareness about clinical trials via pharmacies.
15. Grassroots Education Efforts (00:21:57) The need for grassroots efforts to educate communities about clinical trials and the pharmacy’s role in this education.
16. Training Programs for Pharmacy Teams (00:23:29) Adam highlights the development of specialized training for pharmacy team members to enhance their understanding of clinical trials.
17. Pharmacists as Trusted Information Sources (00:23:31) Discussion on the significance of pharmacists as credible sources of information in clinical research.
18. Study Design Involvement (00:24:22) Exploration of pharmacists’ roles in study designs and their potential as principal investigators.
19. Pharmacy Technicians’ Opportunities (00:26:16) Overview of apprenticeship programs for pharmacy technicians to support clinical trials.
20. Pharmacists’ Evolving Clinical Role (00:27:22) Examination of the shift in pharmacists’ roles towards more clinical responsibilities.
21. Microfilming Technology (00:28:45) Introduction of microfilming as a technology to streamline prescription filling and reduce pharmacist workload.
22. Specialty Pharmacy Management (00:29:53) Discussion on pharmacists’ involvement in managing specialty medications and patient counseling.
23. Translating MTM to Research (00:30:21) Comparison of medication therapy management processes to patient follow-up in clinical research.
24. Building a Site Management Organization (00:32:59) Insights into establishing a site management organization for clinical trials at Walgreens.
25. Privacy and Patient Data Consent (00:35:21) Emphasis on patient privacy and consent processes in clinical trial recruitment.
26. Patient Recruitment Process (00:36:07) Description of how Walgreens recruits patients for clinical trials while ensuring privacy.
27. Opting In and Out of Research (00:38:52) Clarification on patients’ options to opt in or out of research participation.
28. Communication with Patients (00:41:01) Discussion on leveraging existing communication tools for patient outreach in clinical trials.
29. Pharmacy Education Evolution (00:42:20) Overview of changes in pharmacy education to include clinical trial training.
30. Same Team Segment (00:45:01) Adam discusses the importance of networking and engaging with organizations in the clinical research field. He also talks about discovering and participating in research committees and working groups.
31. Closing statement (00:47:52) Justin encourages listeners to follow and subscribe to related podcasts on the CITI Program platform. He also mentions CITI Program’s continuous addition of new courses, subscriptions, and webinars for listeners.

Adam Samson: So right now, the pharmacy profession as a whole is moving towards what can we do more in clinical, within the clinical domain, and we think that this is really a great opportunity that clinical trials could be one of those things that’s allowing them to practice at top of their license.

Justin Osborne: Welcome to On Research with CITI Program, your favorite podcast about the research world where we dive into different aspects of the industry with top experts in our field. I’m your host, Justin Osborne, and I appreciate you joining. Before we jump in, as a reminder, this podcast is for educational purposes only. It is not designed to provide legal advice or legal guidance. You should consult with your organization’s attorneys if you have questions or concerns about the relevant laws and regulations that may be discussed in this podcast. In addition, the views expressed in this podcast are solely those of our guests.

At the beginning, you heard a clip from Adam Samson, my guest this episode. Adam is the head of clinical delivery operations for Walgreens Clinical Trials. I sat down with Adam to discuss the evolving role that the world of pharmacy plays in clinical research. Pharmacists and pharmacy techs are having more and more opportunities to take part in clinical trials, and Adam shares some of the reasons why this evolution is going in this direction, from being known and trusted healthcare professionals in our communities to the skills and clinical practices that easily translate to the research world, there are plenty of valuable insights that Adam shares as key takeaways for any research organization, namely, to consider how best to utilize pharmacists and techs and research in the future.

So without further ado, I hope you enjoy my discussion with Adam. All right, well, Adam, it’s nice to see you. Thanks for coming on the podcast.

Adam Samson: Yeah, absolutely. Thanks Justin. I really appreciate you having me on.

Justin Osborne: Yeah, yeah. So to start us off, can you give us a little bit more about your background and then how you got into research and then what role you’re in now?

Adam Samson: Yeah, absolutely. So like so many others, it’s the cliche, I fell into research. I was a registered dietician. I would probably be the world’s worst dietician because I’ve spent almost no time practicing and on clinical trials as part of an internship and very quickly fell in love with it. Worked as a clinical research coordinator for a few years, and that transitioned into roles of increasing responsibility at the site and then moved into the CRO level. It took a pretty traditional path, being a monitor project manager. Spent a few years in academia, small stand at a pharmaceutical company just prior to the pandemic. And then during the pandemic, I was an early employee at a DCT company.

Then about two and a half years ago, in June of 2022, I joined Walgreens in my current position as head of clinical delivery operations, and now, my primary role here at Walgreens is to help unlock the massive capability that we have here, both in terms of team members, pharmacists, and others who are already rooted in these communities, but also the physical infrastructure and assets that we have and the relationships with the patients that come to see us every day at our approximately 8,000 Walgreens locations.

Justin Osborne: Wow. Yeah, that’s quite a background, and weaving your way through the industry from the site to the CRO sponsor and now Walgreens, it’s quite the journey you’ve been on.

Adam Samson: Yeah, yeah, it’s been a fun ride.

Justin Osborne: That’s awesome. Well, so we’re going to talk about pharmacy and pharmacists and their own research. So to dive in, I guess to the topic, I did want to set the stage first and hear your thoughts about the current role that I guess pharmacies, including pharmacists or techs even, what role do they currently play in clinical research? Just to help everybody sort of set the stage here.

Adam Samson: Yeah, so I think throughout my career, I’ve had interactions with pharmacists in different capacities as part of clinical trials when I was at the site level, especially, either large fully dedicated clinical trial sites or academic medical centers will have pharmacists who are part of the study team who are there to help manage the investigational product. Oftentimes, they’re the ones that are going into the systems to randomize patients, they’re administering the doses, they’re taking all the necessary steps to ensure that there’s accountability of the medication itself. So this is something that we see across the site ecosystem. Well, at a sponsor and CRO, you would see pharmacists in roles including things like they might be a sub-investigator on certain studies, especially post-market type studies. You can see them in medical monitoring type roles, SMEs that are contributing to protocols. So I think there’s a range of different areas where we already see pharmacists participating or playing a role within the clinical research industry. And I think that increasingly, we’re seeing that role have an opportunity to expand into other things as well.

Justin Osborne: That’s great. That’s great. I appreciate that. I feel like, so on the site side, I know you mentioned at the academic more medical settings, obviously, they have the pharmacist, do pharmacists still play a similar type role when you get to the research sites that are maybe independent sites, don’t have a hospital connected to them necessarily, more academic than healthcare?

Adam Samson: Absolutely. I mean, anecdotally, both the sites that I worked at as well as sites that I visited while I was a monitor that were larger and fully dedicated to clinical research tended to have at least one pharmacist who was there to… Research pharmacist is even a term that is sometimes used, not always well-defined, but the idea being they really run that part of the operation. They’re on the 1572, they’re delegated by the principal investigator to really take ownership over the investigational product management. You’ll hear terms like an investigational drug pharmacy or an investigational drug service that these companies as well as large academic medical centers will have, which is really a niche area for pharmacy team members.

Justin Osborne: Yeah, no, that’s good. That’s good. I appreciate that, sort of fleshing that out a little bit. So in your opinion, I guess, and in your experience, what are some of the specific benefits that you think pharmacists and techs and pharmacies in general bring to the research world?

Adam Samson: I mean, in general, I think we see a whole range of different skill sets coming into clinical research. We see there are obvious folks who are pulled in, right? Nurses, nurse practitioners, PAs, MDs, DOs. But then we see dieticians like myself. We see others within the allied healthcare arena, medical assistants, and some even who are not from the medical field. So when it comes to the role or I would say the specific things that pharmacists, pharmacy techs can bring to the table into clinical research, just starting off, even without having that foundational knowledge and trials, they already have a good foundation that’s built on education and certification around things like medical terminology, certainly depth of knowledge when it comes to drugs, drug-drug interactions, working with patients and patient workflows. All of these are kind of the building blocks of what we tend to instill in coordinators, investigators, and others. And I think it’s a really great foundation to have as they start to embark on learning more about clinical trials and really diving into some of the more complex activities that we have.

Justin Osborne: That’s a good point, and that kind of makes me think about to your point, that the more complex trial designs that are coming out, a lot of this stuff, I feel like back in the day, when we were focusing research studies on very, very specific conditions, very specific populations, and as our capabilities and research have grown, the complexities have gotten a little deeper. And so to your point, pharmacists and even techs have that experience that sort of crosses all indications, right? Because drug-to-drug interactions, it’s about the medicine and it’s about the interactions in the human body, not necessarily a cardiac condition. You know what I mean? So I feel like that’s a good way to think about these. They’re more generalized, I think their experience and expertise it seems.

Adam Samson: And another thing I would add there too is they already come from a highly regulated field and they come from a field that is really heavy on documentation. In research, we have the ALCOA principles, they might not use the same terminology, but at the same time, they’re accustomed to recording things contemporaneously to making sure that there is a record that tells the story of that pharmacy patient. And much of that, again, is a good foundation to then layer on the specific regulations around clinical trials.

Justin Osborne: No, that’s a great point. Yeah, that’s a great point. So thinking about research and not study design specifically, but just where the research industry is going, I mean, decentralized trials are coming up more and more, of course, talk a little bit about where you see the move to more decentralized trials, I guess inviting more pharmacists into that world. Does that play a role in this? Do you think that there’s going to be more opportunities for pharmacists to get into research or be involved in research because of this sort of decentralized model push?

Adam Samson: I do. Yeah, I think so. So I think as we move into this phase where over the past few years, we’ve been leaning more into this concept of decentralized trials… When I was working at a DCT company during the pandemic, DCT meant we’re going to do as much as we can in the patient’s homes so that we don’t have to bring them into the clinic and expose them to additional risk. I think that what we learned throughout that was that can work, but there are times where patients don’t necessarily want you in their homes. Quality can be an issue. It’s hard to have consistency, especially when you have highly complex procedures on certain clinical trial protocols.

And as I was stepping into Walgreens, the thought was this is really the next best thing. If I can’t have the convenience of someone coming to my home to do these procedures, then at least I can go to my local pharmacy or another type of space that can conduct these procedures in a way that it’s fully compliant. It just expands our ability to provide consistent, convenient access. And it also helps to leverage some of these spaces that are out there in the retail pharmacy ecosystem in a new way, that is just an overall added benefit to these communities.

Justin Osborne: Yeah, no, I mean I think the whole DCT model, I feel like it does lend itself to this world that you’re in the pharmacy world specifically, because like you said, the resources are there already. And maybe you can speak to this too, in the traditional clinical trial space, they talk a lot about recruitment is always the big hurdle, getting people in these studies, and they talk a lot about the way to improve recruitment in a traditional healthcare setting is to have the physician involved, right? Because people trust their physician generally, and if your physician’s asking you to take part in a research study, you’re more likely to do it. I feel like there’s a similar relationship with pharmacists and possibly even more so in certain cases, in certain areas. So can you talk about that and maybe some benefits around the relationship that people have with pharmacists?

Adam Samson: Certainly. There are immense data to show that patients have a great level of trust in their pharmacists, and a lot of that comes from this is someone that they are seeing more frequently than their primary care provider, if they have a primary care provider or specialists. This is someone oftentimes who’s been in their community with them for 10 plus years. They are trusted providers within these communities. And a lot of what we’re trying to do as part of our Walgreens clinical trials business is demonstrate those proof points, because really the onus is on us to show the industry that this model indeed works. It’s done in a highly compliant way and that patients receive this in a positive way. So we have some early proof points and some case studies we’ve put out, but at this point, everything that we’re seeing is showing and demonstrating, and even my anecdotal experiences as I travel out across the nation to identify new regions to have trials in, I see both interests and engagement from patients.

And something that I wasn’t certain that there would be, but I’m very glad there is is that pharmacists and pharmacy team members are genuinely interested in providing this as an option to their patients. I think we’ll probably dig into this more later, but just to touch on one thing, which is I think oftentimes, people have a hard time envisioning what it would look like to go to a Walgreens or to another retail pharmacy space and be in a clinical trial. And I think we all have that experience of you go to a retail pharmacy and the pharmacy team is very busy, they have a strong workload as we would expect. So much of what we’ve done when the question is, well, how can pharmacists now carry this burden in addition to everything else? This isn’t something we’re dropping in their laps. We are bringing in a team of experienced clinical researchers, putting them in the site, and then we have an alliance with the pharmacy team so that there are warm handoffs.

There are things that they can do to help that early conversation where they have the trust with the patients and say, “Hey, there’s this opportunity for you, if this treatment regimen you’ve been on is working well,” or some other thing that they know about these patients, and then do that warm handoff to the coordinator team. So we kind of get the best of both where we maintain that trusted relationship between pharmacy and patient, but we don’t overburden the pharmacy team members by expecting them to basically now pick up an entirely new skill set and add that to their existing workload overnight.

Justin Osborne: Yeah, no, that’s a great point. And actually, let’s dig into some of these potential hurdles. Because I feel like what you just brought up about the time, obviously, everybody that’s gone to a retail pharmacy to pick up their medications has waited in line and seen the frantic pharmacy. It’s a lot, right? It’s a lot on the pharmacy to manage that. In the physician world, in the hospital setting, usually physicians have time carved out. It’s whatever their models are for conducting research, they have certain time allotted for their clinical activities and then certain time allotted for research activities, and so it’s a balance. In the pharmacy world, are you saying that that is a similar approach that you’re taking, that you’re sort of building it into the ecosystem that already exists there from a pharmacy clinical setting or?

Adam Samson: That’s exactly what we want to do, and my boss, Ramita Tandon, our chief clinical trials officer, since the beginning, two and a half years in, she said, “We’re going to take a crawl, walk, run approach. We are not going to go into these pharmacies again and force this as something new onto them without providing the adequate training infrastructure and get ourselves set up well first.” But long term, the idea here is we’re starting to already look at some of these things. How can we both get those pharmacists the training that they need to be able to do this in a way that’s compliant, foundational training like GCP/HSP training, but then also understand their workflows well enough to be able to say, well, if we gauge 0.5 of an FTE to this pharmacy, whether it’s a tech or part of the pharmacist time, and you couple that with some of the other things that Walgreens is doing to help decrease pharmacist burden and help them practice at the top of their license, we will, over time, continue to step up the role that those pharmacists are playing in these clinical trials.

But first and foremost, I don’t want to be the guy that they’re like, “Who’s this guy coming in here? He’s never worked behind the pharmacy. He doesn’t know what our challenges are.” We actually have a couple pharmacists on our team, one in particular who’s been with Walgreens more than 10 years. He reports directly to me, and he helps us a lot with this pharmacy alliance that we’re building, this idea that we can be a one Walgreens experience. A patient comes in, where a consumer comes into Walgreens, we have a front of store retail side where we have a back of store with pharmacy and we have healthcare that we’re providing as well. We don’t want that to be a disjointed experience. And I think you’re seeing that from other players as well in the retail pharmacy space or even just the retail space, trying to, as they integrate healthcare operations into their broader portfolio, how do you do it in such a way where you’re bringing team members that are already there along with you on the journey?

Justin Osborne: Yeah, no, it sounds like the way that everybody should be approaching research if you’re building out a new program, you know what I mean? Even if you’re a small institution trying to grow research program, it’s a very similar model, it sounds like.

Adam Samson: Very similar, and that’s one of the things that I like to… When we are talking to new potential sponsors is… For the most part, I mean, there are some fully dedicated clinical trial sites and big site networks that’s all they do, is run trials. But historically, and still many of these trials, they’re taking place in physician’s offices and other areas where there is both clinical care and clinical trials happening, and they have to be able to balance that workload. And there are certainly benefits to that, both to the patient and also to the site’s ability to enroll because you have that living, breathing network of patients that are coming in and you’re helping them with their care journey more than just clinical trials, but kind of end to end.

Justin Osborne: Yeah, and as you were talking about that, I feel like I guess I’m curious in your opinion on this, from an educational standpoint, you’re in a position where the retail pharmacy world is obviously very connected to the communities that they’re in. One of the biggest hurdles in general for clinical research is the lack of awareness or the lack of education to the general public about what research is. What role do you see, I guess, retail pharmacies in general play in the education of the general public on research?

Adam Samson: Yeah, I think we should play a significant role along with others, and I think that it’s one of those things that is shared across our industry, is how do we better inform patients about clinical research before they are approached with a clinical trial? Because oftentimes, what you don’t want is that patient is approached for a clinical trial for the first time, learning about what clinical research is when they’re already having a very challenging time in their healthcare journey.

So we, at Walgreens, one of my peers, Kendal Whitlock, who is head of our digital optimization and also our community engagement, she has this term which is surround sound. So the idea, we have 20 clinical trial locations spread across eight states. Before we go in and activate one of those sites to participate in the trial, Kendall and her team are working to determine what is the best way to start engaging that community. We obviously have patients coming into those, or consumers coming into those locations every day. So there are opportunities for pharmacists to start doing some initial conversations with patients. We have brochures and the flyers that we can use as general education, and that starts to help as patients come in.

But then even beyond just who’s coming into a Walgreens, we want to be able to activate the broader community and have done a number of community events where we’re going out and working with, whether it is faith-based organizations or other community events that we can come into, put a couple of people there in the field and just put on a pin that says, “Ask me about clinical trials,” or to lay some of that foundation along with some of the other providers that are there in the region.

Justin Osborne: That’s great. That’s great. No, I agree completely. I mean, obviously everybody is in this together, and that’s a known issue in research that we’re all dealing with, but I’m always interested to hear how the entire system of research, I guess, works together to educate the population. Because again, for us that work in this field, when you tell your friends and family what you do, most of them don’t actually understand what research means.

Adam Samson: And the only way to do it is grassroots. It’s one community at a time or multiple communities that you’re trying to provide this to, something that we invested in early on. Because we think that even if the pharmacy team members are not necessarily on the delegation log, if a patient comes in and says, “Oh, I’m here for my trial visit,” or, “I heard about this,” we want them to feel informed, so they learn about the studies we are doing. And we developed a training program that is specifically targeted to pharmacists. It is a relatively short program. It is required for any of our pharmacy team members who are on one of our 20 sites to take. It covers GCP and HSP, but it does it… We created the program specifically because when I went out there and looked for something off the shelf with tons of GCP and HSP trainings, but none of them that I could find were really tailored to a pharmacy audience.

So we created that. We launched it, it was actually at the beginning of this year, within our learning management system. We’ve opened it up to all of our approximately 70,000 pharmacy team members. They can get continuing education, some certification around that, and many have elected to do it. And I think that’s part of the broader, how do you educate the community? You educate the leaders and the other people who are interfacing with these patients who are trusted providers.

Justin Osborne: Yeah, I think you’re absolutely right. And again, the source of the information being the pharmacists and whatnot, those trusted people matters. This information isn’t coming from some corporate commercial kind of thing. It’s like these are real people talking to their community about research. That’s good. So I wanted to, I guess, just to talk for a second about the study design. So we’re talking about pharmacists being involved in studies and the techs and all that stuff, and we’re talked about how you’re ramping up, at least in your situation, getting them involved and the crawl, walk, run mindset. Does this mean that these studies that you’re going to be doing, are the pharmacists acting as the PI of the studies and then the techs, the coordinators, essentially? What’s the setup?

Adam Samson: Yeah, so great question and I think the long-term vision for us, and just to kind of… As a benchmark for me, I always look back at the few years that I spent at the Duke Clinical Research Institute, and there were oftentimes studies we were doing, especially like population studies, population case studies, and post-market studies, where we had pharmacists who were the principal investigator, and they had a sub investigators, an MD or DO who could provide that medical oversight, but they were really the ones who are running the show. We loved that idea of maybe not PI at first, but sub-investigator on trials, and we’re looking at that, and I think that when it comes to the pharmacy techs, it’s a really great opportunity for us both at Walgreens, but also, as you know, the clinical research industry is always short on staff.

Oftentimes, CRAs and CRCs tend to be the big PIs as well, but CRCs in particular is an area that we’re focused on as we look at pharmacy technicians who oftentimes are a few years in the role and are looking for other things that they can do, either additives to their existing role or as a career progression to find a different path. So we are actually looking at some apprenticeship programs that we can put in place as a pilot program for some pharmacy technicians.

Again, much like you would have in a medical office that’s doing both trials and clinical care, these technicians would likely be doing as part of their time, supporting clinical trials as a coordinator, doing things like picking vital signs, collecting data, we could get them certified for phlebotomy. And then more long-term, we really do want to look at… So right now the pharmacy profession as a whole is moving towards what can we do more in clinical, within the clinical domain? And we think that this is really a great opportunity that clinical trials could be one of those things that’s allowing them to practice at top of their license.

Justin Osborne: Oh, that’s great. No, and I’m glad you brought that up. Talk about the trajectory of pharmacists over the past decade or so in terms of their shift to more clinical. Because I know they have gone more into the clinical setting, and again, because we talked about a lot of examples here with the physicians leading the research, and that is the sort of traditional research model, and I think that’s just our healthcare model that physicians lead medical innovations obviously. But as pharmacists have continued to move more and more into the clinical setting with their skills and capabilities and what they can bring to that table, how do you think that this will impact clinical research?

Adam Samson: Yeah, I think the first part of that question is what are we seeing in terms of pharmacy and a broader role within clinical care outside of clinical trials? And we are seeing that, and something that we at Walgreens are very focused on at the policy level and also at the operational level here is finding ways to free up pharmacist time to be able to have those additional responsibilities. Not to dive too deep into that, but there’s this really cool thing that Walgreens and some others right in the space are doing. For us it’s called micro-fulfillment, it is basically distribution centers that are located in regions that actually fill prescriptions, especially for routine prescriptions so that when your doctor orders Justin’s medication to be sent to this pharmacy, to you, it’s all the same experience. You show up at the pharmacy, your medication’s there, but actually it was filled off site through some really great technology with robots and AI that get it filled all with remote oversight of a pharmacist, and then they’re delivering those prescriptions, sometimes decreasing that store, that pharmacy’s overall burden on children prescriptions by 50%.

Justin Osborne: Wow.

Adam Samson: Bringing time for them. Yeah, it’s significant to do these things and of the one main call-outs I’ll note is just around specialty pharmacy, biologics, cell and gene therapies, these are things that it’s no longer just the pharmacist hands you the prescription, asks if you have any questions and then you’re on your way. These are drugs that really need follow-up. So they go like medication therapy management, MTN, and this is something that our pharmacists are doing where they are counseling patients. They are counseling them sometimes 30, 45 minutes on specific medications to make sure that they’re adherent. Sometimes, it always matters, but more specifically with specialty meds, also helping them understand and navigate any potential drug-drug interactions, any side effects they may be having in coordination with their broader care team. These type of activities are really taking the pharmacists and helping them to contribute more significantly to the patient’s overall care.

Justin Osborne: Yeah, I mean, you talking about MTNs there, and I feel like how do you… Because that happens in any research study, you have to follow the patients, figure out what’s working, what’s not working. I almost feel like it’s a one-to-one, you could easily translate the MTN process that’s in place now with pharmacists into the clinical research setting. I guess why aren’t we calling them MTNs in research? You know what I mean?

Adam Samson: To your point, we need to coin a phrase. Maybe we can do it now. We’re also looking at something of a charity at our clinical trial sites where we’re saying, you have your coordinator who you can rely on for a number of different things. You have your pharmacist, you have your principal investigator, you have your sub-investigator. Oftentimes now, we have a dietician involved in another of these studies or other allied healthcare professionals, and it helps to kind of surround this clinical trial participant with a number of different healthcare professionals that have their own specialty. That way, it’s not all on the PI either or it’s not all on the coordinator. It allows them to focus in on those areas. We’re always going to need physicians, MDs and DOs to be doing physical exams and assessing adverse events, but if we decrease the overall burden that they have on any one study, well, that maybe makes it so that they can be doing additional studies that they have that support.

Justin Osborne: Yeah, no, that’s true. That’s true. Well, so I want to jump back into some of the hurdles, because the time and the ramp up of building a program, like you said, getting people trained up and getting this sort of thing built that you’re doing in the pharmacy world for clinical research, it all makes sense, but besides time and effort to do all of that stuff, what are some other hurdles that you’re sort of looking out for as you’re building this program?

Adam Samson: Back to the crawl, walk, run. We wanted to start off with a few studies, which we launched at the beginning of this year within this space that be called trial conduct, meaning we do some other things than our biopharma services, including just helping sponsors and their sites connect with patients who are Walgreens patients, but they don’t come into Walgreens for their procedures. We do some real-world evidence work.

But as we were doing that, I was out there with a team looking at different potential locations to stand them up. We stood up a couple of locations, had some really great outcomes on those first trials, and has allowed us to very quickly now take that, what was working on a small scale, and ramp it up for this flu season as we have a couple studies here this season. As we’ve gone from a couple sites to 20 sites, what we really needed to do was build out an SMO, or a site management organization. Or in essence at this point, Walgreens, as a clinical trial site network, is part of our clinical trials business.

So things that we’ve looked at that would certainly make it more difficult for us if we didn’t have it in place is the right way to have consistency across these sites, the right way to make sure that we have good access to the type of staff that we’ll need to support that pharmacy team as we’re doing our own clinical trial work. And also the right technology is another pillar, making sure that we’re not lining the walls of a Walgreens location with source binders as we’re all accustomed to regulatory [inaudible 00:33:36]. So building that strong central team, which is kind of the core of our SMO, has been something that is a real focus for us as we go to expand and take what we’ve done a small scale, do it on a large scale. Having everything electronic helps with that consistency.

It enables our site quality and quality assurance teams to have real time access and visualizations to see where we have trends and protocol deviations, adverse events, any other things so they can quickly drill down and know how and when to intervene. So that’s been probably the outside of just the physical infrastructure building and building those strong connections and relationships with pharmacy team members. Building that SMO capability as well as the central team has been honestly equally important as we scale.

Justin Osborne: Yeah, and like you said, as a site network, you have to have all of the functionality that any other research site network has. I mean, like you said, there’s a lot of regulations to protect and cover, make sure everyone’s doing this the right way. Okay, so I do have another question, thinking about some of the potential hurdles, and I guess we talked about the educational piece and how important it is to educate the community in general, but now I’m thinking as a customer of a retail pharmacy, am I to expect now that retail pharmacies are doing research now that basically you’re just sitting on my data and everybody else’s data that… Are you asking me or are you just taking my data now? Now I’m already in research. Behind the scenes, I don’t even know about it because you’re involved in research now. You know what I mean?

Adam Samson: Yeah, and I’m so glad that you asked that question. So I’m an operations guy. I tend not to go to that first, but man, one of the most important things that we look at here is privacy and making sure that we are doing all of these type of things above board and with the proper consent. We have 130 million or so people that come to Walgreens and trust us with their prescriptions. We’re a 120-year-old brand, I don’t want to be the guy that messes that up. We work very closely with our privacy teams to ensure that patients have opted in to receive these type of messages. And it might help if I take a step back just to say, how do we actually recruit patients for trials?

Justin Osborne: Yes, please.

Adam Samson: So we have a database, much like any other health system or other would. We have a data science team who receives the protocol. They then develop a cohort of patients based on eligibility criteria and proximity to sites. So they look at what data points we might have and say certain page, race, any other number of factors we might put in, you’re taking this medication, you’re not taking that medication. We generate a cohort and then we outreach to those patients. Before we outreach to those patients, there are many layers of checks to say, has this patient opted in to receive these types of messages, yes or no? If they have, they might have said, “I want email only or text only, or both.” They might have said, “I’m willing to have you include a certain level of PHI,” meaning the first couple letters of medication.

It is a whole ecosystem in and of itself that I am very fortunate to have a team of lawyers and others who are specialized in this area that are doing this to support our trials business as well as the broader company so that we are sure, we’re confident when we send out those messages or we pick up the phone as part of our contact center and reach out to those patients, that they are indeed consented to be able to go through this. Beyond that, if a patient is interested, it seems like they qualify, oftentimes, we need their full medical record, like any other site would. So at that point, we would engage the patient and ask them if they’d be willing to share their medical records, retrieve them on their behalf. There’s of course, the informed consent that happens for the protocol itself. So it’s many layers, but we take privacy very seriously. Again, it’s core to our Walgreens brand to make sure that we treat patients with dignity.

Justin Osborne: Yeah, no, that’s great. It’s nice to kind of walk through the actual process a little bit too, because I imagine that for the average person who doesn’t understand research fully and know that we have so many regulations around this, that that would sort of be an easy leap for people to make that, “Oh, you’re probably just using my information anyway.” But I guess, so back to get in the weeds a little bit again, your process that you described in the opt in, if I’m presented with that question and I say, no, am I ever presented again or do I have the option to go back in to change my mind if I change my mind?

Adam Samson: Yeah, I mean, certainly, if patients change their mind, they’re often approached, whether it’s right there at the pharmacy counter or elsewhere, on our website for clinical trials, they have an opportunity to opt back in if that’s something that-

Justin Osborne: Okay.

Adam Samson: Absolutely. But once a patient has opted out, they fall off our list and we don’t engage with those patients unless we have a reason to make that change that’s initiated by the patient.

Justin Osborne: Yeah. Yeah.

Adam Samson: I’ll say in general, we’ve gotten very good reception from our patients, and part of the reason for that is, so we have reached out in two and a half years, and I might get this number wrong, because it is constantly going up, of course, but somewhere around seven, 8 million patients for clinical trials, which might sound like a lot. It is, but when you compare that to 130 million people that we have coming in versus the amount of work that we’ve done, the fact that it’s been on two and a half years, there’s nothing to… We could have reached out to 130 million. We’re trying to be very targeted so that you are not getting some random text every time we have a new study that says, “Hey, Justin, you want to participate in this Alzheimer’s study,” that it is much as we can, we are narrowing down that cohort to those folks who are most likely to qualify, and then putting them through a pre-screening process before engaging beyond that.

Justin Osborne: No, that makes sense. I feel like, again, everything we’re saying just reminds me of something else that’s in the healthcare side of this, in the hospital setting, and I feel like it was a game changer for when MyChart stuff kind of came out and then healthcare systems started to be able to use that as a recruitment tool in certain cases. I feel like retail pharmacies already have, for the most part, pretty good communication avenues and tools built, like you’re saying, so that you can build these programs and communicate with the patients, which is a huge first step in getting people in the studies.

Adam Samson: I mean, that’s a big advantage that we’ve had stepping in. Again, even though we’re an independent business, being able to lead into some of these existing workflows and technologies that are there, to, like you said, outreach to patients or some of these other things, and to be able to do it in a way that we’re highly confident, maintains HIPAA and other privacy regulations, has been a big benefit, and just another way that retail pharmacy and pharmacies in general can contribute to the clinical research ecosystem, because they have a lot of these assets of whether software expertise, physical or otherwise, that they can already start to bring to bear. The big thing is just making sure as companies look to get into the space, that you bring on the right expertise, because privacy, all these type of things can vary, of course, from between clinical care, pharmacy, clinical trials.

Justin Osborne: Yeah, that’s good advice. So just to jump back a little bit, again, to the evolution of pharmacists and getting more into the clinical space, talk about some of the… I guess, the changes that have occurred or that are occurring that you know of all the way at the beginning for pharmacists in school and education and all that stuff. How has that evolving?

Adam Samson: So this is an area that we’re highly interested in at Walgreens and clinical trials, and one that we’ve been working closely with our colleagues at the American Association of Colleges of Pharmacy. So this is an organization that, of course, what’s core to what we do here. I learned about a year and a half ago that AACP had a great interest in incorporating more clinical trial education into core pharmacy curriculum. Pharmacists have been receiving education about clinical trials forever, but this would be either additional extension programs or specializations or even increased core curriculum around trials. And so we’ve been working with AACP and others, including the Walgreens Dean’s Council, which has deans from colleges of pharmacy, to try and see how we can support that effort, take some of the trainings we’re putting together, some of what they’re doing, and really start to, like you said, do it at the ground level so that pharmacists, while they’re in school and by the time they’re graduating out of school are well-versed in trials and understand whether, just like physicians, is this something that I want to have as part of my practice and my career?

Justin Osborne: Yeah, I will say clinical research has been good on this front, and from the education standpoint, I feel like there’s more and more… There used to be maybe one certification out there, and it starts at one university. Somebody just makes a short program. Now there’s degrees and there’s very targeted clinical research focus areas and opportunities out there. I feel like pretty soon, it’s no longer going to be the sort of, how did I fall into research shtick that everybody has, people are getting to learn about it sooner and make a choice that they actually want to be in the industry. So that’s good to hear that this is happening in the pharmacy world.

Adam Samson: Absolutely.

Justin Osborne: Well, thank you, Adam. I really appreciate you taking the time and talking through the pharmacy world with us.

Adam Samson: Yeah, Justin, I really appreciate you having me on and hope it’s useful for listeners.

Justin Osborne: Absolutely. Absolutely. So we’re back. I’m still sitting here with Adam. And Adam, it’s really easy to get bogged down in our day-to-day job responsibilities, but I do believe that most of us stay in this research industry because we actually care about the impact that we’re making and we want to make a difference. So can you share an experience or an example from your career that has connected you with this idea that we’re all on the same team in research?

Adam Samson: Certainly. And something that I would definitely recommend to people at any stage of their career in clinical trials, but definitely as you’re moving up, engage with organizations such as the Association of Clinical Research Professionals, ACRP. I found some of those to be some of the most rewarding things that I’ve done. They will oftentimes put together working groups that set out to solve specific problems in the industry that can only be solved through cross-competitive or pre-competitive collaborations, they call it. I’ve done some similar things with the Clinical Trial Transformation Initiative. I’m a member of the Health Advisory Board. This is the fun stuff. This is when you get on with… There might be competitors on the line, there’s sponsors, there’s FDA, but again, all that’s kind of washed away. You’re just saying, what are we going to do about… What is DCT? How are we defined? How are we going to regulate it? The big questions, and then drilling down into small working groups to work through those problems, it’s something that I find incredibly rewarding and something that really makes me feel connected to the broader community.

Justin Osborne: That’s fantastic. So if you were to point somebody, because again, you just really highlighted the idea that people in potentially even competing competitors in the same space are on these calls for the higher purpose of helping research move forward. As somebody that’s either new or just not sure where to go, how do you learn about these committees and whatnot?

Adam Samson: The best way to start, I mean, it’s going to sound cliche, but networking. And I think that a great way to do that, especially earlier in your career, is to become a member of these type of organizations. Go to the conferences, make those connections. Don’t be afraid to go up to a member of the board of these types of organizations and express your interest. And oftentimes, you’ll find once you start doing one, you meet people who help get you into the next one. Oftentimes, you won’t see a broad email go out that says, “Hey, do you want to participate?” This is really getting to know people within these organizations by being active member, and then you’ll find yourself with opportunities to be able to participate in some of these things.

Justin Osborne: That’s fantastic. And again, I feel like because it takes a certain type of person, I feel like, to be in our industry and stay in our industry anyway, I feel like we tend to attract more people in our industry that are more proactive, I feel like, and interested in getting involved in helping and moving things forward. So that’s great advice. So thank you again, Adam. This was an awesome discussion. I appreciate your time, and we’ll talk soon.

Adam Samson: Likewise. Thanks Justin. And yeah, anyone who’s interested in chatting, feel free to reach out to me. You can reach me on LinkedIn.

Justin Osborne: Be sure to follow, like and subscribe to On Research with CITI Program. If you enjoyed this episode, you may be interested in other podcasts in the CITI Program universe, including On Campus and On Tech Ethics. You can listen to all our podcasts on Apple Podcasts, Spotify, and other streaming services. You should also review our content offerings regularly as we continually add new courses, subscriptions, and webinars. Thanks for listening.