Big retailers expanding into health care delivery increasingly see a growth opportunity tapping their huge customer bases to recruit participants into clinical trials.
Why it matters: The moves by Kroger, Walgreens and Walmart, among others, could create a more diverse pool of subjects and expand access to cutting-edge treatments. But there are concerns, including whether there are enough safeguards to protect sensitive patient data.
What they're saying: "The reality is, we're trying to build the right highway into our communities to bring trials closer to where they are," said Ramita Tandon, Walgreens' chief clinical trials officer, noting the pharmacy giant has 8 million to 9 million people visiting its stores day-to-day.
- Walgreen's clinical trial business, part of its $109 million U.S. Healthcare unit, has eight signed contracts, including with biotechs Prothena and Freenome for an experimental Alzheimer’s treatment and a colorectal cancer screening test, respectively.
What it looks like: Retailers say they are able to identify and tell patients that they are eligible right at the pharmacy counter.
- "Right now, what does a patient do? They go to Clinicaltrials.gov and that doesn't make sense," said Jim Kirby, chief commercial officer for Kroger Health.
- He said customers are in their stores or pharmacies regularly and already have a "trusted relationship" that its providers can use to reach patients, particularly in vulnerable communities.
Yes, but: Retailers still have to invest in more capabilities, including buying the appropriate technology to capture and safely store patient information, per a recent Ernst & Young report.
- And CVS Health recently opted to wind down its two-year-old clinical trials business, so it could focus on core operations.
The big picture: The clinical trial market is already $50 billion market expected to grow at an annual rate of 5.8% and top $78 billion in 2030, according to Grand View Research. Incumbents research businesses include Icon, Syneos Health and Charles River Laboratories.
- Analysts have mixed views about retailers' forays into the business. While patient recruitment isn't as lucrative as other business lines, life science companies have cash and are looking for partnerships, Peter Bonis, chief medical officer at Wolters Kluwer Health told Axios.
- "They have very deep pockets and they write checks quickly," Bonis said, adding retailers can make a strong argument they can efficiently enroll the right patients. "Getting the patients quickly is really important. Time is money here," he said.
Zoom in: Retailers point to dismal past recruitment efforts in arguing the trials business is ripe for disruption. Only about 5% of Americans have ever participated in a trial — and diversifying participation to underrepresented groups hasn't borne fruit over the years despite a federal push to improve representation.
- An analysis of more than 100 trials published in JAMA in December found women were underrepresented in pandemic trials of antiviral treatments, and sponsors didn't recruit enough Black and Asian participants for human studies on COVID vaccines.
- COVID also shook up the entire market as studies were suddenly put on hold due to lockdowns and resources shifted to address the pandemic.
- Pressure increased to move research to decentralized trial models in which follow-up visits were conducted via telehealth, and data was collected using wearables or lab tests at local health care facilities. That corresponded with consumers getting more accustomed to and interested in remote care models, per PricewaterhouseCoopers.
The other side: The Ernst & Young report notes the retailers' ambitions require new capabilities centered around remote patient identification, recruitment, digital monitoring, home treatment, data capture and aggregation and security
- Bonis said CVS' pullback makes sense, because clinical trial recruitment is a highly-regulated space that requires getting patient consent, working with institutional review boards and responding quickly if patients have side effects.
- Beyond that, companies like Walgreens are already juggling multiple new health business lines at a time when COVID-era business is drying up, Elizabeth Anderson, analyst at Evercore ISI told Axios.
What to watch: Even without disruption, the federal government is pushing to ensure improved clinical trial recruitment.
- A 2022 law requires more diverse patients in clinical trials, and the FDA will soon begin requiring researchers and companies seeking approval for late-stage clinical trials to submit diversity plans, Bloomberg Law writes.
- The FDA released new guidance on decentralized trials in May, Regulatory Focus writes.
Editor's note: This story has been corrected to reflect Jim Kirby’s title as Kroger Health’s chief commercial officer, not its senior director of business development.
