Kroger headquarters

Kroger enters clinical trial business

Kroger Health has established a clinical trial site network to increase reach and access to research studies.
Sandra Levy
Senior Editor
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Kroger Health, the healthcare division of The Kroger Co., announced the establishment of its clinical trial site network in conjunction with pharmaceutical industry sponsors, contract research organizations and health systems.

The announcement comes with Kroger's first trial in active recruitment for colorectal cancer gut and immune health observation.

In collaboration with Persephone Biosciences, Kroger Health is actively recruiting for the ARGONAUT clinical study (NCT04638751) to identify microbiome-based biomarkers indicative of colorectal cancer. Beginning in the Toledo, Ohio-area, select Kroger pharmacies and its affiliate, The Little Clinic, locations will enroll its initial cohort of 55 people with a variety of colorectal cancer risk levels to advance the understanding of gut and immune health. During the next year, Kroger Health plans to enroll additional participants and increase its locations.

"With our team of more than 24,000 healthcare professionals, under the umbrella of America's grocer, we are positioned at the nexus of food and healthcare, which provides us with the unique opportunity to increase accessibility to clinical trial opportunities," said Colleen Lindholz, Kroger Health president. "As a trusted community healthcare destination, we envision a future where our work transforms the clinical trial landscape and provides expanded trial access to the people we serve."

[Read more: How retail pharmacy is entering clinical trial services]

According to the CDC, of cancers that affect both men and women, colorectal cancer is a leading cancer killer in the United States. It has been proven that colorectal cancer screening saves lives. Approximately nine out of 10 people whose colorectal cancers are found early and treated appropriately are still alive five years later.

Kroger Health is seeking participants with the following risk factors:

Age 45 and older who need their standard of care colonoscopy;

Age 18 or older with one or more first-degree relatives with a history of colorectal cancer; and

Those who have had three or more polyps found during a colonoscopy or who have a personal history of colorectal cancer.

A growing body of evidence shows the bacteria living in the gut may influence an individual's risk to develop colorectal cancer. The data collected from this trial will be used to develop personalized medicines and find cancer-specific indicators that may help guide future treatment and preventive strategies, such as utilizing food as medicine.

Kroger said that 90% of the U.S. population lives within five miles of a pharmacy, and 51% of all Kroger stores are located in socially vulnerable areas. With select Kroger pharmacies and Little Clinics now serving as clinical trial sites, America's grocer is expanding its commitment to health care by creating research opportunities in the communities where customers live, work and eat, the company added.

Alongside the grocer's data analytic capabilities, Kroger Health is able to engage a wider range of the population in clinical trials. Digital tools, virtual care visits and personalized communication will facilitate patient retention throughout the study's lifecycle. In addition, its clinics, dietitians, pharmacy services and relationships with other healthcare organizations enable Kroger Health to offer end-to-end clinical trial management within a variety of preventive and therapeutic areas, the company said.

[Watch DSN: Kroger Health’s Lindholz highlights importance of Food as Medicine platform]

"Through our collaborations with health systems across the country, we can nimbly work to optimize the patient experience to improve healthcare delivery and maintain continuity of care while expanding the frontiers of care and treatment," said Jim Kirby, chief commercial officer of Kroger Health. "This is the first of many clinical trial opportunities that will utilize us as an alternative to the traditional clinical trial and research organization model."

People interested in participating in the ARGONAUT study can call 1.833.317.0661 for more information on qualifications and study background.