By Ed Miseta, Chief Editor, Clinical Leader
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Clinical trial recruitment has always been a challenge for drug developers. Research has found that almost 80% of clinical trials fail to meet enrolment timelines. Additionally, global data analysis of terminated trials within Clinical Trials Database found 55% of trials were terminated due to low accrual rates. That challenge creates delays in getting needed, life-saving drugs to patients.
A new development could potentially change the recruitment challenge. In 2021 and 2022, CVS, Walgreens, and Walmart, three companies with pharmacies and access to millions of patients, officially entered the clinical trials space. The patient access capabilities of all three organizations may change the way drug developers access patients while also solving the industry’s patient diversity problem.
The first announcement came from CVS, which announced Clinical Trial Services in May 2021. The new business was positioned to deliver solutions for COVID-19 and beyond with its community presence, data capabilities, and health care expertise. In June 2022 when I spoke to Josh Rose, VP, Head of Clinical Trial Delivery, Site Solutions and Strategy for CVS Health, the company had just announced its plan to help drug developers improve studies.
Rose notes CVS has 9,000 retail pharmacies that are located, on average, within 10 minutes of 85% of the U.S. population. CVS also has approximately 1,000 MinuteClinic locations in the U.S., each providing in-person and telehealth visits. The MinuteClinic locations are places where CVS customers can also receive services such as vaccines, physicals, and other services.
CVS also hopes to assist drug developers with the collection of real-world evidence. CVS has one of the largest patient databases in the country via the relationship it has with its pharmacy customers and its Aetna healthcare plan. That adds up to 130 million patients the company has information on regarding scripts, medications, and claims. Rose believes that data will provide researchers with valuable real-world data.
Click here to read my article on CVS entering the clinical space.
In June 2022 Walgreens announced it was launching a clinical trials business to address recruitment and diversity challenges while also redefining the patient experience. In 2021 Walgreens played a large role in helping to distribute and administer COVID-19 vaccines. Walgreens currently has 160 million consumers and patients in its 9,000 stores located across the U.S. In fact, 78% of the U.S. population lives within five miles of a Walgreens location. That reach allowed the chain to administer 67 million COVID vaccines.
Walgreens has made changes to its business model to support clinical trials. VillageMD is a primary care company in which Walgreens has a majority ownership position. VillageMD has primary care practices co-located with Walgreens pharmacies in neighborhoods throughout the U.S. Walgreens Health Corners is another growing initiative. The Health Corners will have dedicated space in the stores as well as an app intended to help customers improve health outcomes.
In November 2021 industry veteran Ramita Tandon was hired as the company’s chief clinical trials officer and she began building the clinical trial organization. A key goal of the organization was to take lessons learned during the pandemic and apply them to a new generation of trial delivery models. One of the lessons learned was the necessity of decentralized and hybrid models to meet the needs of patients.
Another goal of Walgreens is to advance the use of RWE in clinical research. This will involve reviewing clinical treatment records and pharmacy records to find ways to leverage data. The Walgreens RWE engine will identify patients, improve patient engagement, and support the patient journey. It will also provide researchers with insights into a patient’s condition and their disease progression.
Click here to read my article on Walgreens entering the clinical space.
Walmart is the third entity with a pharmacy that hopes to make a huge impact on clinical trials. The company announced its entry into the space in October 2022 with the goal of improving patient recruitment and diversity. Walmart has over 5,000 locations with 4,000 of those stores in HRSA designated Medically Underserved Areas (geographically isolated or medically vulnerable areas).
Walmart hopes to focus on trials that will have the most significant impact on those populations. The therapeutic areas would include diabetes, obesity, and cardiovascular disease. Walmart hopes it will be able to assist pharma partners with protocol design in those studies.
“Recruitment is something that will really differentiate us,” said Dr. John Wigneswaran, Walmart’s chief medical officer. “Our engagement levels are much higher than what is currently being seen in the industry. I think a lot of that is related to the fact that we do have a very deep relationship with our customers. Once a patient becomes involved with a study, we are sensitive to messaging them the way they prefer to be messaged. Finally, once the study is complete, we can learn the results of the study, follow the patient, and improve their care.”
Click here to read my article on Walmart entering the clinical space.