Jill Pellegrino of CVS Health Clinical Trial Services on Using RWE to Improve Clinical Trial Efficiency and Applicability
By Brittany Wade
March 7, 2023 | In 2020, retail pharmacy giant CVS launched CVS Health Clinical Trial Services in response to pharmaceutical manufacturers’ requests for potential participants in COVID-19 trials. After engaging more than 300,000 patients, the company recognized its unique ability to service the clinical research market through increasing patient recruitment efforts, encouraging equitable participation, and conducting real-world data (RWD) analysis.
Today, CVS Health Clinical Trial Services has worked with more than 30 pharmaceutical companies, conducted over 50 clinical trials, and secured nearly 33,000 participants across cardiovascular, respiratory, gastrointestinal, immunological, and neurological therapeutic areas.
The company’s newfound success in research services is undoubtedly credited to its strategic positioning as a pharmacy, research site, and real-world data hub. Their direct access to patients through various touchpoints makes extracting real-world data and evidence relatively seamless, and each branch of the company works synergistically with the others.
“We have the data, but we also have that capability to stand up and execute a pragmatic trial,” Jill Pellegrino, vice president of recruitment and RWE at CVS Health Clinical Trial Services, tells Deborah Borfitz, Clinical Research News senior writer and Scope of Things podcast host. “Going direct to patient is powerful, and it’s not used that often in clinical research… I saw the value and benefit of CVS’ rich dataset and its expansive reach to introduce [patients] to research opportunities,” says Pellegrino.
CVS Health boasts a vast dataset covering “100 million lives” and uses the data to match eligible patients with upcoming studies, educate participants on available options and trial benefits, and boost industry-wide wellness initiatives. Though RWD contains some inherent biases, Pellegrino insists that directly engaging the patient and working with experienced data scientists and engineers to maximize data integrity is the cleanest way to ensure a comprehensive dataset.
As patients sign consent forms through CVS’ MinuteClinics—a collection of over 1,100 medical clinics embedded within select CVS pharmacies across the country—CVS gains permission to collect data from other internal sources: pharmacy records, Aetna CVS Health claims, and electronic medical records. External lab, imaging, and medical reports are also included if needed. CVS Health’s pipeline auto-generates high-quality data, diminishing the need for data tokenization or gathering de-identified data and combining it for one unified dataset.
A One-Stop Shop for Trial Services
Trial sponsors find value in CVS Health’s use of direct-to-patient recruitment strategies to increase trial enrollment and patient engagement rates. There is also a heavy focus on recruiting historically underrepresented and diverse populations through the now 80 MinuteClinics certified to conduct clinical trials.
“Depending on where those patients are located, they don’t always have the ability to participate in a clinical trial,” says Pellegrino. “To be most effective in driving large patient populations into trials, you need to meet the patients where they are. A subset of our clinics can run clinical trials directly in the community so that we can give access to patients who don’t always get the chance to participate.”
CVS Health also works with pharmaceutical companies after a drug is placed on the market to provide insights into patient trends and behaviors and identify logistical barriers to accessing treatment.
Pellegrino admits that many companies have yet to take advantage of CVS’ full scope of services. She says, “We feel that [we] can add value to the entire process… We think there’s a significant opportunity to use [our] health data in the planning process when the drug is in clinical development and after the fact when it’s on the market.”
As more pharmaceutical companies rely on RWD to inform research and development processes, CVS Health hopes to become a one-stop shop for clinical services while making a significant health impact on underserved communities. Helping research partners develop proper protocols and establish inclusion and exclusion criteria can increase diagnosis and treatment adoption rates in populations previously unable to seek care.
Undoubtedly, CVS has all the makings to become a clinical research powerhouse, and Pellegrino promises more to come. The company’s roadmap includes increasing its value through patient registries, expanding into more complex therapeutic offerings involving oncology, and exploring a new recruitment model through its partnership with Aetna. Aetna CVS Health plans to extend clinical trial benefits to their employer clients, attracting an untapped employee-patient population for future clinical studies.