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Retail pharmacies look to disrupt clinical trials

Retail pharmacies look to disrupt clinical trials

CVS Health and Walgreens see business opportunities in promoting participation in medical research, especially among segments of the population that have historically been underrepresented in clinical trials.

Scientists struggle to recruit and retain study subjects in about 80% of trials and less than 5% of the U.S. population has taken part in clinical research, according to the National Institutes of Health. Moreover, the demographic makeup of trial participants rarely reflects the nation’s racial and ethnic diversity, which weakens research findings and limits the evidence on how new therapies work in different groups.

CVS Health and Walgreens believe they have a role to play and are betting that pharmaceutical and medical device companies will contract with them to help carry out trials. Both companies declined to provide revenue projections for their nascent clinical trial businesses.

Chain drugstores have physical presences in communities that are home to people typically left out of clinical trials. These companies also have troves of data that can identify customers who could take part in medical research.

CVS Health and Walgreens contend they can make trials less expensive and better. While medical technology research and development spending is accelerating, the pace new therapies reaching the market hasn’t, said Jennifer Byrn, CEO of Javara, a company that assists healthcare providers with incorporating research projects into clinical care.

Challenges to overcome

The pharmaceutical industry spent $83 billion on research and development in 2019, according to the Congressional Budget Office, nearly 10 times more than 40 years ago, adjusted for inflation. The average cost to introduce a new drug is between $1 billion and $2 billion.

Recruitment and retention are among the costliest aspects of drug development. Recruiting a single trial participant costs more than $6,500, according to Johns Hopkins University and George Washington University researchers. Replacing a patient who drops out of a study costs $19,500, they found.

Stanford University and Boston-based Massachusetts General Hospital researchers found that 80% clinical research conducted uses white participants and that Black, Hispanic, Asian and Native American populations are overlooked.

Historically, medical research has been conducted in-person at academic institutions, which limits participants to those within the researchers’ geographic reach. Phase III clinical trials, which test safety and efficacy on large numbers of subjects, face dropout rates of up to 30%, which can slow progress, according to the researchers. In addition, nearly 80% of studies are delayed by at least a month because of recruiting shortfalls.

Clinical research organizations have sought to address these shortcomings by locating studies in more regions and by easing participation through remote technology. Rather than patients traveling to central locations, they can go to satellite sites nearer to their homes.

The approach limits in-person visits and brings research closer to where people are, which relieves a burden that hinders recruitment and retention, said Yasmeen Long, director of FasterCures at the Milken Institute, a think tank. They are also tapping into an large amount of medical data to identify patients who are eligible to participate in trials.

Using retail locations and targeted communications may improve and accelerate recruitment, which could result in speedier research at lower cost.

“Time costs money, and the more that we can shorten that time frame, the more cost-effective the drugs can be,” said Clare Grace, chief patient officer at Parexel, a clinical research organization. “That’s our overall goal: to get drugs to patients faster and more cheaply with a robust safety database.”

Pharmacies to scale trial operations

CVS Health formally launched its clinical trials division last year and Walgreens recently announced it plans to stage trials by the end of this year. These initiatives build on both companies’ investments in healthcare delivery and the relationships they strengthened with pharmaceutical companies during COVID-19 vaccination programs.

CVS Health and Walgreens have sought to diversify beyond their core drugstore businesses into broader healthcare services with expansions and acquisitions in primary care, home health, telehealth and patient engagement software. Together, they have more than 18,000 retail locations. These companies also possess technology infrastructure that enables them to conduct portions of clinical trials remotely.

The pharmacy chains are pitching pharmaceutical companies about their insights into potential trial participants and promising to make research more efficient through better recruitment, demographic information and telehealth capabilities.

“We will then be able to work to accelerate certain parts of the clinical trial workflow, such as finding patients in local markets much faster, which in turn allows pharma to drive benefit in their overall time/investments made in a specific trial,” a Walgreens spokesperson wrote in an email.

One year in, CVS Health has supported more than 30 trials in 15 markets and helped enroll 20,000 patients into phase II, III and IV studies. People of color made up 40% the participants, according to Tony Clapsis, senior vice president of clinical trial services.

The company also recently entered a partnership with Parelex, which already has relationships with pharmaceutical and biotechnology companies, and Javara, which works with providers.

Their combined reach could enable them to administer clinical trials across medical offices and CVS Pharmacy locations, which would integrate medical research into care settings. That strategy has worked in other countries and could enroll as many as 10% of the U.S. population into clinical trials, Grace said.

Involving drugstores in clinical research should benefit patients by making trials more accessible, but won’t solve problems such as staffing and regulatory compliance, according to a spokesperson for Clinical Research Associates, a company that conducts trials.

“We’re glad to see retail pharmacies contribute to clinical research, because their tremendous resources could benefit patients if utilized correctly,” the spokesperson wrote in an email. “If they can help generate awareness of clinical trial opportunities, help patients understand the benefits of enrolling in a study, grow diverse recruitment and help attract more investigators, then patients will be the winners.”

Diversity in clinical research

Achieving more diverse clinical trials requires surmounting major barriers, such as a lack of trust in the medical system among segments of the population and a dearth of racial and ethnicity data, said Otis Johnson, chief diversity, inclusion and sustainability officer at clinical trial technology company Clario, who formerly worked on trial design at the drugmaker Merck.

Clinical researchers are not required to collect information about the race and ethnicity of trial participants. Only 43% of clinical trial results published between 2000 and 2020 included such data, according to the Stanford-Mass General study. Likewise, gender and sexual orientation data collection is lacking, a separate study by the Mayo Clinic found.

The Food and Drug Administration released guidance in April that advises drug and device companies on gathering race and ethnicity data during research, but it remains voluntary and the information is not a factor in the FDA review process, Johnson said.

“I was hoping to have that feeling when I was reading the guidance for increasing patient diversity in clinical trials, but I didn’t—and that’s a problem,” Johnson said. “Because there are no consequences, there are no incentives.”

CVS Health and Walgreens have physical footprints and established brands that may help them overcome trust issues in communities that have been mistreated by medical research in the past, Johnson said.

Their data collection activities will also be significant: CVS Health and Walgreens already have race and ethnicity data about their patients, which they can use to track the diversity of trial participants. For example, CVS Health conducted a study on the effectiveness of COVID-19 vaccines and found that 49% of people who opted to learn more about the research through targeted communication efforts were people of color.

“This could be a big player to help eliminate the lack of diversity and trials that have been for decades. So these new models retail pharmacies, as well as using digital resources, digital technologies, is a great way to not only modernize but really increase that diversity that’s been lacking” Long said.