Clinical trials pave the path to FDA approval of new drugs and new uses for old medicines. It’s a booming business—Clinicaltrials.gov, the National Institute of Health’s central resource for clinical trials, currently shows more than 100,000 trials in process in the United States alone and a further 15,500 that include U.S. and foreign sites. About 20% of those trials are actively recruiting participants.
And the number of participants needed for all those trials continues to grow rapidly. In 2013, about 1.1 million Americans enrolled in a trial, according to a Battelle report. The more than 16,500 active trials for cardiovascular conditions alone require more than 4.5 million patients.
Despite the growing need for participants, just 4% of Americans have ever participated in a trial—and more than 50% have never heard of them, according to a 2017 survey by SubjectWell.
That’s where pharmacists can play a critical role. When asked where they would go to find information on a clinical trial, more respondents to the 2017 survey said they would ask their pharmacist than any other healthcare provider or organization.
Pharmaceutical companies spend more than $2 billion each year recruiting patients for trials, yet two-thirds of studies still fail to reach enrollment goals, according to the Tufts Center for the Study of Drug Development. Many are hoping to leverage the relationships many patients have with their pharmacists to increase enrollment.
Walgreens has long been a leader in clinical trial participation, and its programs illustrate the range of options for pharmacies interested in exploring the clinical trial field. Pharmacists identify customers who have medical histories that indicate eligibility for specific trials sponsored by Pfizer, Merck, Biogen, Novartis, and AbbVie, with whom the chain has established partnership agreements. They then send each customer a letter about the relevant study, along with a number to call for more information. Pharmacists may also attach information about a trial to medication packages and discuss participation in a clinical trial with the patient at pick-up.
Pharmacies that take the referral approach generally receive a small payment for each patient referred, and a more significant sum if a patient enrolls in the study.
Center Point Clinical Services, a contract research organization that specializes in “siteless” trials, offers another option. Pharmacies can contract with the company to assist with blood draws, panels, and profiles needed during clinical trials, giving participants a convenient location for most or all of their study-related activities and reducing drop-out rates. Pharmacies upload the data to a central point, largely eliminating geographic restrictions in recruitment.
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Published December 21, 2018