This trend, which began during the COVID-19 pandemic, may bypass those clinical laboratories and pathology groups that recruit patients for clinical trials, but increase the diversity of the pool of study participants
National retail pharmacy chains are seeking new lines of business in the healthcare market and their efforts could cost clinical laboratories and pathology groups revenue. Their strategy is to identify patients who are candidates for specific clinical trials and connect them with clinical trial managers for enrollment, according to CNET.
This comes on the back of the US Food and Drug Administration’s (FDA) move to decentralize clinical trials, which got started during the COVID-19 pandemic, and support clinical trials that covered a wider swath of the American population.
Dark Daily first covered this trend in “Walgreens Launches Clinical Trial Business with Goal of Leveraging Consumer Data, Technology, and Nationwide Reach to Increase Racial and Ethnic Diversity in Drug Research.” We reported how Walgreens was launching a business to connect customers with clinical drug trials, a venture that adds another offering to the retail pharmacy giant’s growing menu of healthcare services.
Traditionally, there are clinical laboratories and anatomic pathology groups that actively work to connect their patients with appropriate clinical trials (and earn revenue for both the enrollment and doing necessary testing of the patient in support of the trial). Now, following the FDA’s lead, pharmacy companies seem to be working to capture some of that revenue.
“COVID-19 was definitely the impetus for reevaluating how we did clinical trials,” Ramita Tandon, Chief Clinical Trials Officer at Walgreens, told CNET. The interest of retail pharmacies in the business of identifying their patients as candidates for clinical trials is a development that clinical lab managers and pathologists may want to monitor. (Photo copyright: Walgreens.)
Customer Demand for Convenience a Factor
Clinical trials are imperative to the drug approval process required by the FDA’s Center for Drug Evaluation and Research (CDER). The COVID-19 pandemic fueled the FDA’s move to decentralize clinical trials to help pharmaceutical companies recruit subjects for drug testing.
Retail pharmacy chains apparently saw that as the latest opportunity to position retail pharmacies as intermediaries between drug manufacturers and patients.
In response to growing demand for convenient healthcare locations, Walgreens, CVS, Rite Aid, and Walmart have all installed primary care clinics into their retail pharmacies and added vaccinations. Further, after COVID-19 caused retail pharmacy chains to sell over-the-counter SARS-CoV-2 home test kits, pharmacies sought to offer more diagnostic test options to their customers, which would further direct such tests away from clinical laboratories.
Over the last two years, Walgreens, Walmart, CVS, and Kroger have also added clinical trials divisions to their corporate holdings. Among the companies’ stated goals is to make clinical trials more accessible and convenient for their customers, as well as to recruit more trial participants from underrepresented populations.
According to an article published in the Journal of Medical Internet Research (JMIR), “around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies.” This shortfall may delay the creation of useful drugs, medical devices, and other essential treatments.
“If you see the trial is at an academic institution that’s 30, 40 miles away, you’re going to say, ‘Forget it. It’s too far,’” Ramita Tandon, Chief Clinical Trials Officer at Walgreens, told CNET. “But if you can go to a Walgreens that’s maybe five miles away, you’re more likely to participate and complete the trial.”
Creating a More Diverse Group of Clinical Trial Participants
CNET reported that “Pfizer, Gilead, and other biopharmaceutical companies are eager to diversify their patient pool.”
According to the FDA’s 2022 Drug Trials Snapshot, “Whites comprised the majority of patients enrolled in most of the pivotal trials supporting approval of all 37 novel therapies, followed by Asians and Blacks.”
Walgreens, which operates 8,698 pharmacies in 53 states and territories, has installed special clinical trial centers at 15 pharmacies and has approximately one dozen clinical trials in various stages. Tandon said more than two million Walgreens customers have already been contacted about participating in clinical trials.
In January, grocery giant Kroger announced its first clinical trial partnership with Persephone Biosciences to locate subjects for a study on gut health and its influence on colorectal cancer. Data collected from this trial will help develop personalized medicines and discover cancer-specific indicators that may be beneficial in guiding treatments and preventative measures.
Kroger Health operates nearly 2,200 pharmacies across the US, including 11 specialty pharmacies and 225 clinics.
In October of last year, Walmart announced the creation of the Walmart Healthcare Research Institute (WHRI), which will focus on innovative interventions and medications to help communities that are unrepresented in clinical trials, such as older adults, rural residents, women and minority populations.
Walmart operates over 3,000 pharmacies in 49 states. Ninety percent of Americans live within ten miles of a Walmart, which translates to the retailer being able to reach a large number of candidates for clinical trials.
Study findings published by marketing research company Precedence Research illustrate how the business of clinical trials generated more than $48 billion last year and is projected to reach over $83 billion by 2032. (Graphic copyright: Precedence Research.)
CVS Discontinues Decentralized Clinical Trial Business
CVS Health was the first pharmacy to launch a clinical trials program back in May 2021. However, in May of this year, the company announced it was shuttering that portion of its business.
CVS Health expects to fully phase out its clinical trials unit by the end of 2024, citing “the need to align existing businesses with its larger corporate strategy,” according to BioSpace.
“Fully decentralized models preclude a huge swath of possible research because of safety and regulatory concerns,” Steve Wimmer, Vice President of Partnerships at decentralized clinical trial recruiter 1nHealth, told BioSpace. “It’s difficult to conduct such trials in a standardized manner. I think [CVS] may have imagined that a clinical study visit wouldn’t be that different from the primary care visits they already do. But for interventional, go-to-study trials, it’s not the same as a primary care visit.”
According to the US National Library of Medicine, more than 38,000 registered clinical studies occurred in 2022. As of August 24 of this year, 26,237 clinical studies have been registered on clinicaltrials.gov.
There are clinical laboratories and anatomic pathology groups that actively work to connect their patients with those clinical trials. Though pharmacy companies’ clinical trial recruitment programs may reduce revenue for those labs and pathologists, the increased participation in such trials by greater numbers and more diverse populations of people could advance the development of new lifesaving treatments and therapies, which is good for everyone.
—JP Schlingman
Related Information:
Clinical Trials Are Now at Your Local Drugstore. What That Means for You
FDA: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
FDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
US National Library of Medicine: Trends, Charts, and Maps
Healthcare Clinical Trials Market
Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis