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Health care executive Shelli Pavone discusses her article “Why retail pharmacies are the future of diverse clinical trials,” highlighting the urgent need to improve representation in clinical research. Shelli explains how barriers like mistrust, cost, and lack of access have historically excluded women and minority populations, leading to less effective treatments and persistent health disparities. She describes how leveraging retail pharmacies—trusted, accessible community hubs—can decentralize trials, expand recruitment, and boost retention. Listeners will gain practical insights on how pharmacies’ existing infrastructure can be adapted for clinical research, why inclusivity matters for health outcomes, and how patient-centered innovation can reshape the future of medicine.

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast. Today we welcome Shelli Pavone. She is a health care executive. Today’s KevinMD article is “Why retail pharmacies are the future of diverse clinical trials.” Shelli, welcome to the show.

Shelli Pavone: Thank you for having me.

Kevin Pho: All right, let us start by briefly sharing your story and then telling us why you decided to share this article on KevinMD.

Shelli Pavone: I have been in health care for my entire career, over twenty years at this point. I started my career working for pharmaceutical and biotech companies, and then in about 2015, I transferred to health care startups. In 2019, I founded my company, Enlightened. We connect health care professionals with market research firms, consulting firms, and pharma clients, and they launch studies and projects with our vetted network of health care professionals.

Kevin Pho: All right. Your article talks about how retail pharmacies are the future of diverse clinical trials. Tell us why you decided to write it, and then for those who did not get a chance to read it, tell us about the article itself.

Shelli Pavone: Yeah, so I wrote this article because we are really at a moment where anything with the word “diversity” is being challenged, and in a way, it will have very far-reaching consequences. When it comes to clinical trials specifically, we really have not yet reached equality, and so chipping away at any progress we have made will have a significant impact on the people traditionally left out. I wanted to address the issues with diversity in clinical trials, but I did not want to be doom and gloom about it. I think I have talked in many instances about the issues why we struggle with diversity in clinical trials, and I have certainly talked about ways to fix it. But I wanted to address those gaps this time by looking at the way that we can use existing infrastructure.

I have always talked about the infrastructure and the things that we need to build, but I think that this article addresses something that is already in place, and that is really looking at the retail pharmacy landscape and how we can utilize those locations to include more people in clinical trials, specifically people from diverse backgrounds.

Something that was really interesting is in 2024, a research report found that more than three out of four Americans bought products from drug stores or pharmacy retailers. I believe the statistic is something like ninety-eight percent of Americans are within five miles of a retail pharmacy. That demonstrates the accessibility of those businesses across populations and communities. So why not utilize that infrastructure as a way to carry out decentralized clinical trials? That is really the basis of the article. Of course, the article talks about why diversity is so incredibly important in clinical trials, and I think this is a really interesting possible solution.

Kevin Pho: All right, so let us talk about that last point about the importance of diversity in clinical trials. Give us an example or a sense of the scope of the issue and the statistics that show how homogenous clinical trials are today. And then get to why diversity is important specifically as it relates to clinical trials.

Shelli Pavone: Yeah, absolutely. Statistics on clinical trials today, even though there has been a lot of work done to address diversity in clinical trials, we are still seeing about seventy-five percent of clinical trial participants being white. Around sixty percent of those participants are also male. We are looking at oftentimes drugs being studied in populations where the disease may not be most prevalent, and then we are also missing out on important data and information about the people who need these therapies the most.

Kevin Pho: And what are some traditional methods investigators use to diversify clinical trials?

Shelli Pavone: Well, some of the things that have been done in the recent past have been really looking at the cultural competency and the education from the study. So investigators do outreach programs in communities where they are looking to increase trial enrollment. Oftentimes there are large pushes to try to get people that have a higher prevalence of disease into the trials. The issue with that is that a lot of the trials are traditionally hosted out of academic medical centers, and the accessibility of those centers is certainly not as prevalent as the accessibility to retail pharmacies. So that is something that has failed us in a way in trying to bring more diverse participants into clinical trials.

Kevin Pho: All right. So now go into more detail in terms of your idea about using retail pharmacies as a way to diversify the representation in these clinical trials. What would that look like?

Shelli Pavone: So decentralized clinical trials are becoming more and more ubiquitous. There are retail pharmacy companies that have attempted this; I know CVS and Walgreens have. But really the whole point of it is having the retail pharmacies themselves be that clinical trial touchpoint. So, if a patient needs to be seen as a part of a clinical trial for, say, routine blood work or to pick up the medication that they are being administered, instead of driving to an academic medical center, they could just go to their local Walgreens and have their blood drawn or pick up that medication. A lot of the calls and the other touchpoints with clinicians that take place during these clinical trials can be done virtually. We are really limiting the amount of in-person engagements that have to be done.

But when there is a necessity of an in-person engagement, somebody can travel to their local Walgreens instead of going, in some cases, an hour or further to get that care. I think that statistic about the amount of individuals who are within five miles of a retail pharmacy is really helpful in understanding how much more accessible these retail pharmacies would make clinical trials. There is a very big difference in saying how close are people to academic medical centers versus, “Do you have a Walgreens or a CVS in your town?”

Kevin Pho: So what would that look like for patients? They would walk into a pharmacy and pick up a certain medication, and that would trigger a flag that there may be a clinical trial associated with that. So from a patient standpoint, what would that look like?

Shelli Pavone: From a patient standpoint, if there are clinical trials that are being done out of a retail pharmacy, that pharmacy is typically going to advertise to those individuals within the community. But yes, that is important data that we get from those pharmacies. They have information about the medications that patients are on, and it may give them additional information about certain trials that patients may be eligible for. I am sure that they can ask patients when they come to Walgreens if they are interested in understanding more about clinical trials, if they are interested in being contacted about clinical trials, and then they can go to those individuals who might be a fit and ask them if they are willing or interested in participating.

There is a lot of data that we have from pharmacies, and patients certainly can have a say in whether or not they would like to be contacted, but I think it opens people’s eyes to the possibility of participating in trials. If they are given that education from a Walgreens or a CVS, then they may have a little bit more understanding about what they have access to in their community.

Kevin Pho: And what would be an example of the scope of clinical trials that may be associated with retail pharmacies?

Shelli Pavone: There are a lot of clinical trials that go on every year for simple things like flu season. We want to make sure that we are testing for the new flu vaccines or other kinds of medications that may treat seasonal issues. Those are very often done out of a retail pharmacy, and so they are accessing a much larger patient population. They might enroll patients in a clinical trial for a flu vaccine or for a decongestant medication or something along those lines.

Kevin Pho: So in areas where this has been implemented, talk about some of the results and the effectiveness of this approach.

Shelli Pavone: So in this instance, we have seen an uptick in the enrollment of individuals from diverse backgrounds. We are starting to see a shift in those statistics around strictly white people enrolling in clinical trials versus people of color and women as well. Just generally, people that would not be reached in the marketing for clinical trials or people that would not have access to clinical trials are considering clinical trials and participating in clinical trials. This is still a new model, so we do not have a ton of data yet, but it is definitely something that has shown that we can get more people enrolled in trials and we are reaching populations that we would not previously have reached.

Kevin Pho: So, correct me if I am wrong, when I walk into a CVS, I get the impression that the pharmacists are pretty busy, and there are staffing issues and what not. So do retail pharmacies have the capacity for the additional burden of potentially enrolling or drawing blood from patients for the purpose of clinical trials?

Shelli Pavone: So typically, those individuals that are overseeing the clinical trials are not generally going to be the staff pharmacists or the retail pharmacy staff. They are going to bring in specific study coordinators and PIs and sub-Is for these individual studies. What that looks like is a new study structure that is going to be carried out from these retail pharmacies. Many times the PI themselves may be remote, and patients may just interact with them virtually. Then you will have a nurse or study coordinator staffed at the locations, and they will be there for the specific dates and times when individuals are coming in to get a checkup as related to the clinical trial or a blood draw. The infrastructure is really set up separately from the general operations of a retail pharmacy.

Kevin Pho: So tell us what we have to look forward to. What is the penetration of this approach, and do you anticipate this becoming more widespread? What do we have to look forward to?

Shelli Pavone: I think one of the things that is really interesting about this approach and some of the research that has been done is that when given the chance and the appropriate resources and access, people will not only choose to be included in clinical trials, but they will be active participants. When you look at that information, I think that we have a great opportunity by utilizing these locations to enroll a lot more people in clinical trials. The more clinical trials that we can do, and the more studies that we have robust enrollment in, the more new therapies we can bring to market.

The other thing that I think is really interesting from this model is that there are a lot of clinicians and physicians who are being given the opportunity to be PIs and sub-Is over clinical trials. One of the things that we have looked at in the past for increasing the enrollment of diverse populations in clinical trials is making sure that the PIs or sub-Is, or the clinical trial staff in general, are also from the same communities, and that helps go a long way when it comes to establishing trust. These decentralized clinical trials are giving more individuals an opportunity to gain experience as PIs and sub-Is as well. I think that this model in itself will increase the enrollment in trials, it will increase the number and types of trials that we are able to do, and it will also increase the diverse populations that are enrolled in trials as well.

Kevin Pho: We are talking to Shelli Pavone, she is a health care executive, and today’s KevinMD article is “Why retail pharmacies are the future of diverse clinical trials.” Shelli, let us end with some take-home messages that you want to leave with the KevinMD audience.

Shelli Pavone: Absolutely. So I think that one of the most important messages I can give here is that we still need to continue to advocate for equal access to health care, which includes, of course, clinical trials. This is something that we have seen movement on in the past and there are some better guidelines in place, but we need to keep our eye on the ball and recognize that a failure to include all voices in health care innovation not only perpetuates health care inequalities, but it casts a shadow on the potential of the medical advancements that we can have.

Kevin Pho: Shelli, thank you so much for sharing your perspective and insight, and thanks again for coming on the show.

Shelli Pavone: Thank you so much for having me.