CVS Health, the parent company of CVS Pharmacy, has announced its Clinical Trial Services initiative. The effort will involve collaborations with pharma, biopharma, and clinical trial organizations, in an effort to come up with innovative solutions and ways to effectively generate real-world evidence (RWE). According to the company, the newly formed business will start off by focusing on ramping up in three core areas:
- Patient recruitment, leveraging analytics national outreach, and community connections to build awareness
- Clinical trial delivery, including decentralized options
- RWE generation and studies, measuring the impact of devices and therapeutics in real-world settings
Tony Clapsis, general manager and vice president of CVS Clinical Trial Services, spoke with Outsourcing-Pharma about the initiative, the firm’s history of clinical research support, and the importance of streamlining and expanding trial services.
OSP: Could you please share how the idea behind CVS’s Clinical Trial Services came about—was it borne from internal conversations, discussions with professionals in the study industry, a mixture?
TC: Long-standing structural issues and low patient enrollment and engagement are negatively impacting clinical trial viability and outcomes. Finding a large, diverse group of qualified participants willing to go to a clinic to participate in a trial over multiple visits and years, issues with medical center scale and capacity, and patient access and retention are becoming increasingly difficult to solve.
Clinical Trial Services defines CVS Health’s focus on bringing together, scaling, and expanding the company’s clinical trial support services to pharmaceutical companies and other clinical research organizations. CVS Health has been supporting clinical trials across our Enterprise for years, including in our Coram CVS Specialty Infusion Services, Aetna, and Healthagen businesses.
Through the COVID-19 pandemic, CVS Health’s collaboration with the pharmaceutical industry helped facilitate clinical trials for investigational COVID-19 vaccines and treatments, highlighting how CVS Health’s footprint in local communities, analytics capabilities, and expertise in providing health care services provide a unique platform for us to engage participants across diverse communities.
Eighty-five percent of Americans live within 10 miles of a CVS Pharmacy, and we provide more than 125 different health care services at nearly 10,000 locations, in homes, and via virtual care. Half of our CVS Pharmacy locations are located in communities ranked high or very high in the Centers for Disease Control and Prevention Social Vulnerability Index.
OSP: I understand the Clinical Trial Services team plans to work with pharma and trial companies with this initiative—can you share any more details about the firms and organizations you’ve been working with to date, and/or will be working with in the future?
TC: We are working with the National Institutes of Health (NIH) and other pharmaceutical and biotech companies that are driving innovative research, including ongoing work with COVID-19 studies launched last year under Operation Warp Speed. We are building on our history and experience in working with 15 of the top 20 pharmaceutical companies on various aspects of clinical research. I’m sure you can appreciate that due to contractual requirements, we are unable to spare specific details on sponsors or projects currently in market.
OSP: Could you share a little more detail on how CVS Health will help promote progress in patient recruitment—will you be working on direct customer communication about trial opportunities, in-store signage, emails?
TC: Our focus is giving the potential research participant choice. Through the assets and capabilities of CVS Health, we have the ability to essentially meet the patient where they are. We can reach people through direct traditional and in-person outreach as well as patient-driven digital resources about available trials in their communities for which they may be eligible. Even if a person doesn’t decide to participate, there’s value in educating more people about clinical trials.
OSP: Similarly, can you provide more information about the trial delivery aspect—will you be conducting trial services at existing MinuteClinics and/or HealthHubs, constructing new facilities, both?
TC: We have the capability to engage and deliver trial protocol with participants through our retail locations, including HealthHUB locations, home care services offered by Coram CVS Specialty Infusion Services and through digital capabilities.
OSP: Also, could you share more detail about the RWE generation and studies?
TC: Similar to trial delivery, we’re able to leverage our enterprise assets to help conduct retrospective and prospective studies that measure the impact of novel devices and therapeutics in real-world settings.
OSP: Could you share a bit more information about CVS Health’s work to help find qualified volunteers for COVID-19 trials?
TC: CVS Health collaborated with the pharmaceutical industry to help facilitate clinical trials for investigational COVID-19 vaccines and treatments. Using a specially designed digital model and screening protocols, CVS Health engaged more than 300,000 volunteers who met the study inclusion criteria for COVID-19 vaccine trial consideration and helped them connect to studies close to where they live.
A primary objective of our efforts was to ensure representation of diverse populations in the study. Inclusion of individuals from varied races, ages, ethnicities, and gender provides a more complete view of the patient populations that can respond differently to therapies. We are proud to share that close to 49 percent of the individuals in this COVID-19 effort who opted in to learn more were from diverse populations.
OSP: Do you have anything else to add about CVS Health, Clinical Trial Services, or other aspects of the research industry?
TC: We’re focused on increasing access to clinical trials across the communities we serve and creating a better clinical trial experience to help improve participant retention, recruitment and enhance the effectiveness and speed at which new drugs and investigational treatments can reach those who need them.