Retail clinics may be the next frontier for clinical trials

By Dawn Anderson, managing director, Deloitte Consulting LLP

More than two decades ago, a tiny medical office (tucked into the back of a Minneapolis grocery store) began offering routine medical services.¹ This was the beginning of what is now called ‘convenient care’—the idea of offering basic medical services in a retail setting. These petite clinics—usually staffed by nurse practitioners or physician assistants—can now be found in more than 3,000 pharmacies, supermarkets, and big-box retail stores around the country.² Along with making basic care more accessible and affordable, community-based retail clinics could become the next frontier for clinical trials.

Retail locations are probably not suitable for all types of clinical trials. A trial for a new drug to treat lung cancer or a rare disease would need to take place in a medical center. But a trial for a skin-cancer treatment or a drug to treat diabetes, asthma or hypertension might work well at a retail location. This strategy could help expand the locations where trials can take place, which could improve access for patients without negatively impacting traditional trial locations. It could help broaden the reach of clinical trials and make them more patient-centric.

Location, location, location

I've been involved in setting up clinical trials for more than 30 years. Finding and convincing patients to join (and remain in) trials has always been, and continues to be, the biggest challenge. Most clinical trials are conducted in academic medical centers (a typical patient has to travel more than two hours each way to participate). A pharmaceutical sponsor company usually selects hundreds to thousands of locations to conduct their clinical trials. Most of these locations have access to a limited number of patients. Being confined by the parameters of their locations, clinical trials typically face two enormous challenges:

1. Recruitment: At any moment, patients are being recruited for thousands of clinical trials. However, more than 80% of these trials will be delayed due to recruitment challenges.³ Drug manufacturers might spend $2.6 billion to bring a new drug to market.⁴ Every day that a new drug isn’t on the market could translate to $1 million dollars or more in lost revenue, as I noted in my blog about virtual clinical trials. Even small, incremental improvements in recruitment could translate to significant savings. A clinical trial hosted by a national retail chain could dramatically expand the pool of potential participants.
2. Retention: Nearly one-third of patients drop out of clinical trials before they conclude. It’s not surprising. After traveling to the location, the patient often has to wait for long periods of time for treatments and tests and might have to take off work to keep appointments. Asking patients to do this every two or three weeks can be a tremendous burden. Making participation convenient could encourage more patients to complete the trial. Many people live within 10 or 15 minutes of a pharmacy or grocery store that operates a convenient clinic,⁵ and many of those clinics have extended hours in the evening and on weekends. Keeping trials on schedule and reducing drop-out rates could generate enormous financial savings for pharmaceutical companies.

Would retail clinics attract a more diverse population?

The pool of patients who qualify for a clinical trial tends to be limited, and participants usually don’t reflect the overall population. While racial and ethnic minorities make up nearly 40% of the US population, about 80% of patients who participate in clinical trials are white, according to a multi-year study conducted by the US Food & Drug Administration.⁶ The industry has struggled with diversity for years and there is a recognition that some therapeutics could affect patients differently depending on their ethnicity, race, age, or gender. It’s difficult to know whether community-based retail clinics could improve clinical trial diversity, but it is a definite possibility. While some underserved populations don't have access to academic medical centers, community-based supermarkets or pharmacies tend to be highly accessible.

There are typically three main barriers that limit diversity in clinical trials: Trust, access, and awareness. These next-generation clinical-trial sites could address all three of barriers:

• Trust: Patients generally trust their neighborhood pharmacist, and that pharmacist could serve as a trusted messenger. A local pharmacist might be able to identify and recruit patients who could benefit from enrolling in a trial.
• Access: Access is about being able to reach a trial site in a way that isn’t too disruptive to the patient’s lifestyle. Being able to take part in a trial outside of traditional office hours could improve access.
• Awareness: There is also outbound outreach within the pharmacy, which could help build awareness about a trial. Pharmacists, for example, could talk with patients about the potential benefits and tradeoffs associated with participating in a clinical trial. Placards in a retail clinic or grocery pharmacy department might also provide information about upcoming clinical trials.

What are the potential benefits to stakeholders?

The faster companies can complete clinical trials, the faster they can get a new product to market. Moving some trials to retail clinics could help reduce delays and help generate data more quickly. Some retail chains operate hundreds of clinics around the country. That could mean just one contract needs to be signed to access hundreds of potential trial sites across a broad geography. Clinical trials could also create a new revenue stream for retailers. Trials might also help to attract more foot traffic to their stores and could have a positive impact on their brand.

Some clinical trials for COVID-19 vaccines were conducted at urgent-care facilities and other community-based locations. I have spoken with a couple pharmaceutical executives who are evaluating the idea of moving some clinical trials to retail clinics. That will likely require them to train staff and invest time to prepare the new sites for clinical trials. Retail clinics would need to comply with the same regulations as traditional trial locations. It could take time for these organizations to prove themselves as viable clinical-trial sites.

A large pharmaceutical company might have thousands of clinical trials underway at any given moment. Adding retail clinics to the mix likely won’t have a noticeable impact on academic medical centers, but it could help to expand the opportunity for US-based research to reach more local communities. If these next-generation clinical-trial sites can actually recruit more patients into trials, retain them, and improve diversity, it could be a home run for pharmaceutical companies, retailers, and patients.

Endnotes:

1. United States retail clinics markets, analysis & forecasts, 2016-2020 & 2021-2026, Research and Markets, November 2, 2021

2. United States retail clinics markets, analysis & forecasts, 2016-2020 & 2021-2026, Research and Markets, November 2, 2021

3. Sanofi’s digital initiative simplifies patient participation in clinical trials, Sanofi, February 3, 2017, Center for Information and Study on Clinical Research Participation (CISCRP)

4. Innovation in the pharmaceutical industry: New estimates of R&D costs, Tufts Center for the Study of Drug Development, May 16, 2016

5. The evolving role of retail clinics, RAND Corporation, 2016

6. Clinical trial diversity, US Food and Drug Administration, December 9, 2021

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