Walgreens has altered its involvement in the clinical trials enterprise from having trial participants visit its stores for routine site visits to leveraging its 100 million customer database for patient recruitment for investigative sites preferred by five large biopharmaceutical companies.
This new initiative launches as Walgreens winds down its three-year “Clinical Trials of the Future” partnership with Novartis, by which Novartis would use a section of each retail pharmacy as a walk-in site. The goal when that program launched in 2012 was to make patient enrollment and retention easier and enable Walgreens to become closer to consumers.
Now, Walgreens is working with five major pharma companies—Pfizer, Merck, Biogen, AbbVie and Novartis—to help their preferred sites recruit participants from the pharmacy chain’s database. Potential patients live throughout the 25 countries in which Walgreens has 112,800 stores. Walgreens is launching the program with its database of U.S. patients, who live near one of its 8,200 U.S. stores.
“Patient identification and recruitment is the key service we now provide, and it’s growing rapidly,” said Howard Golub, M.D., Ph.D., vice president, clinical research for Walgreens, speaking at IIR’s Partnerships in Clinical Trials conference in Boston. “Based on customers’ medical histories and what sponsors and sites need, we send these customers letters asking if they are interested in participating in clinical studies. If they opt in for more information, they are asked to call an 800 number.”
An example of a letter to a customer might read: “Hello, we are Walgreens. We are involved in clinical research in an asthma study and it requires six visits to a clinic very near you over six months. If you are interested call this 800 number.” Each study has its own 800 number.
Walgreens also might try to recruit trial participants at the point-of-sale, when customers come in to a store to pick up a prescription, by attaching a note to the package. A pharmacist might say, “You might want to look at this note, it describes a clinical study in which you might be interested.”
Golub stressed that all of Walgreens’ patient recruitment efforts are designed to protect patients’ privacy.
“The patient is enrolled at the tertiary care center site or the hospital site,” he said. “We refer—we don’t enroll or consent—but we provide his/her contact information only after getting the customer’s permission so the site can contact him/her directly. The only way we help potential trial participants is if they opt in and call us once they learn about a study.”
Walgreens also will give a prospective participant the option to provide written consent for the pharmacy to contact the patient’s physician to explain the trial and to receive a copy of the patient’s medical chart to perform further eligibility review.
“Once we get permission,” said Golub, “we let the doctor know his patient was eligible for a study and asked us to refer her to [name of site] to potentially participate.”
Typically, Walgreens’ startup for the recruitment process for a trial takes about six weeks, said Golub, adding its organizational approach is more cost-effective than the standard model. Sites also can use patient recruitment firms in parallel to Walgreens to evaluate the cost differences. So far, Walgreens has worked on nine trials in the last eight months.
In the 2012 Novartis deal, the plan was for patients to visit their local Walgreens for routine vital sign checks, reducing the need to travel to investigative sites further away, potentially to speed timelines and reduce costs. But both companies quickly realized the idea was not going to work as planned. Top corporate management changes at Novartis and Walgreens’ merger with large European drug store chain Boots-Atlantic prompted Walgreens to refocus on its core pharmacy business, modify its clinical research business and leverage it powerful customer database.
“The original Novartis study with us was a mismatch between our capabilities then, as we were taking 98% of the recruitment risk and were paid only for each enrolled subject, which was low when we started,” said Golub, who joined Walgreens 14 months ago. “We are not doing studies in our stores in the foreseeable future.”
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