Several years ago, I sat down over a few days with individuals across multiple pharmaceutical companies to understand whether using digital health products would help with clinical trials. At the time, there was a rising interest that using these devices could help inspire siteless clinical trials, help facilitate enrollment and retention of participants and that new digital biomarkers would allow new outcomes to be evaluated for drug approvals. 

The feedback I received was it just wasn't time. Why break the mold, even with its faults, when it was producing the results expected? To engage in novel trial design was a risk with no assured outcome that leadership would likely want to spend money on investigating when so many of its studies were already in the works. Maybe they could use small pilots or certain therapeutic areas to test these concepts and then grow at scale. It looked to be something that would take years to accomplish.

And then Covid happened.

So all these companies that had been crafting relationships across digital health and were considering making the leap towards siteless trials, using new technologies for research, and engaging in novel enrollment mechanics suddenly had to launch. Similar to the capabilities of telehealth being there for over a decade, it took a watershed moment to drive adoption.

Now, as we transition out of the pandemic's peak, the question becomes, what lessons were learned, and where do we go? And for that reason, in my professional area, the push to have community pharmacies become a player in clinical trials is a very interesting topic.

Why does pharmacy want to be involved in clinical trials and patient enrollment?

Haven't heard of this? Ok, well, let me set the scene. Traditionally, CROs and related would identify clinical sites to help enroll patients into clinical studies. Providers and their teams would help identify patients that met inclusion/exclusion criteria and perform the outreach to get them enrolled. They may help with onboarding and clinical data collection at set points during the trial. But there have always been some difficulties in this model, including:

• Having to go to a clinic or provider office for data collection could be a barrier, and even reimbursement for that time may not negate the time off work or needed extraneous costs (e.g., childcare, parking, gas).

• These clinics may be biased in terms of what patients they may have access to and may not be posed in certain demographics or socioeconomic populations that would be needed to help diversify study populations (which the FDA is very interested in having changed).

• Lack of awareness amongst patients is a huge issue as a focus on academic medical centers to conduct research limits community engagement. 

• Trust is another issue whereby some patients may not regard an unknown person coming before their appointment to ask if they are interested in participating in a clinical study may be off-putting.

Let's compare this with a pharmacy model. 9 out of 10 Americans live about 5 miles from a pharmacy. They go to a pharmacy more often than they see their providers. So, from a logistical standpoint, it would seem that the pharmacy could pose a more sensible site for getting patients enrolled in clinical trials. For this reason, the benefits of having community pharmacies involved can boil down to the following:

• Access to a diverse patient population: Community pharmacies serve a diverse patient population, including people from different age groups, ethnicities, and socioeconomic backgrounds. This makes them an ideal location for clinical research enrollment, as they can help ensure a diverse and representative participant population.

• Trust and familiarity: Community pharmacies are often trusted and familiar sources of healthcare information and services for patients. This can help build trust and facilitate enrollment in clinical research studies.

• Convenience and accessibility: Community pharmacies are often located in convenient and accessible locations, which can make it easier for patients to participate in clinical research studies. Patients may be more likely to participate in a study if it is convenient and accessible.

• Increased awareness of clinical research: Community pharmacies can help increase awareness of clinical research studies among patients and healthcare providers. This can help raise the profile of clinical research and increase participation in studies.

• Improving patient outcomes: By participating in clinical research studies, patients can gain access to new and innovative treatments that may improve their health outcomes. Community pharmacies can help facilitate this process by providing information and support to patients who are considering participating in clinical research studies.

• New business models: Thinking beyond the fill is important for pharmacies, especially with the incentive of medication dispensing fees and profit margins diminishing. Having patients enrolled in a clinical study at a pharmacy can help lock them in that location and get financial coverage beyond a payer and, instead, possibly by the pharmaceutical company, which may net some additional profit that makes this an attractive business opportunity. 

Which pharmacies are involved in clinical trials?

Many community pharmacies are exploring how to enroll participants in clinical trials. Many large companies with a pharmacy component are now engaging in this possible business aspect, including:

1. Walgreens: In 2019, Walgreens partnered with clinical trial technology company Medable to offer clinical trial enrollment services at more than 9,500 Walgreens locations across the United States. They could be argued to be the first to call attention to this model amongst the pharmacy chains.

2. CVS Health: By 2021, CVS Health has also partnered with clinical trial recruitment companies to offer clinical trial enrollment services at select CVS Pharmacy locations.

3. Kroger Health: Kroger Health has partnered with Science 37, a technology-enabled clinical research company, to offer virtual clinical trials to patients through select Kroger Health locations.

4. Walmart: In 2021, Walmart announced a partnership with Clinical Research Associates (CRA) to offer clinical trial recruitment services at select Walmart locations. The program is currently available at Walmart stores in Arizona, Arkansas, Georgia, Louisiana, Mississippi, and Oklahoma.

5. Thrifty White Pharmacy: Thrifty White Pharmacy, a chain of independent pharmacies in the Midwest, has partnered with Clinical Pharmacy Services to offer clinical trial medication dispensing.

What are the Pharmacy Organizations' and Associations' stances on having pharmacies involved in clinical research?

Interestingly, many organizations are in full support of this for different reasons. For one, it can help expand access to care for patients who may not have been able to get new treatments in the past. It opens a new business model for the pharmacy and can help those looking beyond dispensing. Lastly, it helps build goodwill for the profession. Some examples of organizations and their work include:

1. American Pharmacists Association (APhA): APhA has developed resources and tools to help pharmacists become more involved in clinical trial recruitment. APhA offers a continuing education program on clinical trial recruitment, as well as a toolkit to help pharmacists get started in recruiting patients for clinical trials. Further reading - APhA's Clinical Trial Toolkit for Pharmacists - https://www.pharmacist.com/clinical-trial-toolkit-pharmacists

2. National Community Pharmacists Association (NCPA): NCPA has a program called Pharmacists Advancing Health through Innovation in Clinical Trials (PAHIC), which provides resources and training to help community pharmacies become involved in clinical trials. PAHIC offers a variety of resources, including webinars, toolkits, and case studies, to help pharmacies successfully participate in clinical trials. Further reading - Pharmacists Advancing Health through Innovation in Clinical Trials (PAHIC) - https://ncpa.org/pahic

3. American Society of Health-System Pharmacists (ASHP): ASHP has developed a program called the Clinical Trials Research Network (CTRN), which provides training and support to pharmacists who are involved in clinical trials. CTRN offers a variety of resources, including webinars, tools, and networking opportunities to help pharmacists successfully participate in clinical trials. Further reading - Clinical Trials Research Network (CTRN) - https://www.ashp.org/ct

4. National Association of Chain Drug Stores (NACDS): NACDS has advocated for policies that support clinical trial recruitment in community pharmacies, including the inclusion of community pharmacies in clinical trial networks and increased funding for clinical trial infrastructure in community pharmacies. Further Reading - Clinical Trials and Community Pharmacies - https://www.nacds.org/policy-advocacy/health-care-priorities/clinical-trials-and-community-pharmacies/

5. Academy of Managed Care Pharmacy (AMCP): AMCP has developed resources and tools to help managed care pharmacists become more involved in clinical trial recruitment. AMCP offers a continuing education program on clinical trial recruitment, as well as a toolkit to help pharmacists get started in recruiting patients for clinical trials. Further reading - Clinical Trial Recruitment in Managed Care Pharmacy - https://www.amcp.org/policy-advocacy/policy-positions-statements/managed-care-pharmacy-role-clinical-trial

Some personal thoughts on pharmacy enrolling patients into clinical trials

While I do find this whole endeavor interesting and really do think it is something that should be done, I have some lingering qualms that I haven't seen widely discussed that I would like to see addressed in the future. After all, this is a topic that has been proposed in the past. It's one thing to have executives and related on stages saying they are going to do this and help patients in the community, but it's another to see how this is delivered in a meaningful way.

So, which pharmacy wins out?

Looking at the above, we can't have every pharmacy operating as a site for clinical enrollment. It's not sustainable. Likely, the issue will be patients will feel pulled from one place to another. People do use multiple pharmacies, generally either due to cost or accessibility factors, and I do not think they would like being bombarded by multiple pharmacists about being in a trial.

More likely than not, it's going to be costs and scalability factors on who wins out. Regulatory concerns are going to be large and a barrier for upfront costs to do this. So if out of reach for smaller companies, then they likely won't get on the bandwagon. Then there's the ability to actually do the community outreach and onboarding etc., with staff (which we'll come back to). The larger chains that have newer store designs with the space may be more likely to engage, especially if they have onsite diagnostics/testing and additional clinical services (e.g., providers).

Who do we recruit?

If one of the core thoughts behind using the pharmacy is to help increase access and improve diversity for patients in the community access to clinical trials, it will then need to deliver on this. My question here is = the outreach component. Will pharmacy teams identify patients to reach out? Will there be advertisements (in multiple languages) in the pharmacy? Which pharmacies will be targeted? We are already seeing some pharmacies close in lower socioeconomic areas, which seems counterintuitive. I'm also a bit worried about incentive measures that may be implemented to get patients signed up, which we've seen as a problem in the past with pharmacies. Imagine if a patient has difficulty accessing medications and is prompted to join a trial because their medications will be covered at the pharmacy during the duration of the trial. 

What Therapeutic areas?

Specialty pharmacies are already involved in some of the more costly medications (e.g., oncology, rheumatology, autoimmune conditions) and clinical research, and most patients with these conditions are driven to those outlets. So, which therapies are going to be a focus for the community pharmacy to target? I imagine that the fit for certain therapeutic areas can be predicted and then cross-referenced with pharmaceutical companies' pipelines and anticipate who may want to play in this space. Overall, I anticipate having community pharmacies engaging in this business won't be able to get to all research areas of focus and maybe more narrow at first than anticipated.

How do we train the profession?

This is probably the biggest grey area for me. What is the involvement of the pharmacy team in all of this? Enrollment I could see feasibility, but I question, with the current workload and metric expectations, how this fits into the workflow without more FTEs. Then there is the training for the team to help in the process. Another question I can see coming is whether we will need to train technicians for patient screening. If the pharmacy team is directly involved, I can see more CEs coming out and possibly certifications. Whether a pharmacist would then have to take certain CEs in their state to engage in this work would be interesting if this takes off. Lastly, space in the pharmacy is limited; where will this be done? We saw how many pharmacists were vaccinating in the aisles during the peak of the pandemic. I think there are many logistical barriers that need to be addressed, and I will be keen to see what is discussed in the coming months about this process.

Do we really want to do this?

I think this is probably going to be a lingering question. I know not every pharmacist is going to want to do this, especially if a metric gets tied to it. I can't imagine anyone wants to have to 'enroll 5 patients in study X' per week. The advantages to our patients I will not disagree with them, and I see substantial benefits. But, again, how this is rolled out will be the key to success. I look at health systems that have a system on how to enroll patients in studies, and I often think about how that may be mimicked. I think there are possibilities, but I can't imagine a pharmacy DM taking point on it. We'll need professional buy-in for this to work.

The Elephant in the Room

To close out, I do want to discuss one aspect of clinical research that I am not hearing addressed by these pharmacy maneuvers. One of the largest issues I hear discussed in pharma is that, yes, enrollment is an issue, but retaining patients is another aspect that needs to be addressed. Having the pharmacy screen and enroll patients, I think, is very feasible, but whether they can keep them in the study is another question that is further confounded by the above issues I have mentioned. The worst-case scenario I can imagine is that the pharmacy can enroll patients but have a higher dropout if not managed correctly, and then this whole endeavor falls apart as the cost-effectiveness isn't panning out. If anything else, I want to hear more about enrollment and how the pharmacy can help retain participants in the study. To me, that would be the selling point of this business initiative.