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Experts in the biopharmaceutical industry have discussed the numerous advantages of recruiting patients in pharmacy settings; for instance, patients are more likely to be interested in participating in clinical trials if they hear about the study from a pharmacist. Now, CVS Health® is utilizing its existing infrastructure to bring clinical trials to the patient by conducting them in community locations closer to the patients' homes. CVS Health is also supporting clinical trials through targeted recruitment efforts and the generation and analysis of real-world evidence, which can be used to optimize trials and identify gaps in care. In this interview, Jill Pellegrino, vice president of recruitment and RWE at CVS Health® Clinical Trial ServicesTM, will discuss this infrastructure and why CVS Health has entered into the world of clinical trials.
Moe Alsumidaie: CVS Health launched Clinical Trial Services in May 2021. How did this business emerge?
Jill Pellegrino: CVS Health has been involved in clinical trials for many years. We formally started Clinical Trial Services after CVS Health collaborated with the pharmaceutical industry to facilitate clinical trials for investigational COVID-19 vaccines and treatments. During that time, we engaged more than 300,000 volunteers and helped connect them to local studies. From that initial success, it was clear that there was an unmet need in clinical trial access that CVS Health could uniquely address. That's really where the concept for the business was born. Since then, we've done much work outside COVID-19, including trials with over 20 sponsors across ten therapeutic areas.
MA: In 2012, I discussed with Walgreens and CVS the potential to enroll patients in clinical trials; they dabbled in the idea but didn’t pursue it then. Why is now the right time to do this?
JP: The pandemic highlighted the significant need for trials to be conducted more efficiently. The industry needed a new way to give more patients access to clinical trials. The traditional way of enrolling in trials does not give everyone a chance to participate. For CVS Health, the timing was right as the company is focused on helping people with their health wherever and whenever they need us.
MA: How can a retail pharmacy like CVS Health contribute to clinical trials?
JP: There are a couple of ways that we do this. First, across our enterprise, we have access to a population of a hundred million people from across all our businesses: our retail pharmacies, Aetna health plan, and MinuteClinics. Our relationship with that population allows us to introduce relevant clinical trial opportunities to them directly. The second area is increasing access to clinical trials across our communities. With CVS Health, more than 85% of the US population lives within 10 miles of one of our nearly 10,000 CVS locations. This reach allows us to bring clinical trials to patients directly in their communities. Our trial-ready CVS Health network, telemedicine, and in-home trial capabilities make it easy for individuals to participate in clinical research.
MA: Pharmacies are evolving from a place of product distribution into a health care destination. How does this trend impact CVS Health and clinical trials?
JP: There is an increasing desire to use the pharmacy as a health care destination. We see this with our MinuteClinic and HealthHUB businesses. Our customer community is very interested in participating in clinical trials and trusts to hear about this from their pharmacy. We conducted a research panel with over 2,000 customers responding. We asked about their knowledge of clinical trials and how they might decide to participate in trials. The response was overwhelmingly positive; 84% said they want to participate in clinical trials with CVS Health, and 68% said they would prefer to hear about clinical trials from the pharmacist, higher than from their physician. People want to participate in trials and see the pharmacy as a trustworthy partner to help introduce them to trials.
MA: Can you tell me more about dispensing medication and having investigators at the CVS Health site? How does that model work?
JP: We have built and continue to grow a site model using our MinuteClinic infrastructure. CVS Health operates HealthHUBs MinuteClinics that offer broader health services that can support clinical trials. Of those HealthHUBs, 80 are considered trial ready, meaning they have a staff of trained nurses, study coordinators, and clinical professionals to conduct trials at those locations. We are also expanding our network of investigators to facilitate trials across our locations. These experienced investigators have done clinical research in their practices and can operate virtually or at our locations. Working with CVS Health can expand their reach and access to patients. Regarding therapeutic areas, we’re focusing initially on vaccines, infectious disease, metabolic, cardiovascular, pulmonology, dermatology, oncology, neurology, and immunology/autoimmune.
MA: How does CVS Health recruit patients for clinical trials?
JP: Our goal is to bring trials most relevant for our customers in their health care journey. We recruit patients from our CVS Health population for studies that we run in our HealthHUBs and at other investigator sites. In either case, we first work with the trial sponsor to understand their protocol and patient criteria. Then we go to our database to identify those that could be a match for the trial and send them an invitation to participate. If they accept, the patient is referred to an investigator site or one of our HealthHUB locations. We're very cautious about patient confidentiality. We always ensure that we protect our patients’ information and do not share any health data with any pharmaceutical company or investigators in the absence of patient consent.
MA: How do you anticipate existing study sites will react as CVS Health starts to grow in clinical trials?
JP: We’ve had positive receptivity from clinical sites; our ability to source patients and use our centers for patient visits or tests is welcomed. CVS Health can be a strong partner for traditional clinical sites.
MA: So, rather than the patient traveling to the site, if they live far away, they can go to a local CVS pharmacy to do blood draws or pick up their medication for refills?
JP: Yes, that's exactly right. This type of model increases patient participation because it's easier for them. In addition to local CVS Health locations, we also integrate telemedicine and in-home nursing capabilities so that they can do specific tests and visits from the comfort of their own home.
MA: How do you use real-world data (RWD) and real-world evidence (RWE) capabilities to support this model?
JP: RWE uses data from a real-world setting instead of a controlled one, like a clinical trial. RWE can be used in many ways. It could be used to understand long-term health and safety outcomes better. It can be used to understand the effectiveness and efficiency of treatments or patient and physician behaviors.
We see that most parties rely on real-world data being pulled from medical records like claims or EML, EMR, and EHR systems. CVS Health is uniquely capable of gathering deeper insights that may not be found in just medical records. This helps to clarify patient behaviors, perceptions, and any limitations they have, like cost or knowledge. These insights are influential to both the usage and effectiveness of treatment. For example, we routinely bring in data on social determinants of health to supplement the clinical data of our patients. We find that that's informative in helping us and our pharma partners understand different variables that could impact select groups of patients' ability to seek treatments.
MA: How can RWD be used in clinical trials?
JP: We think there's a massive opportunity to use RWD upfront in clinical trials. We have found that data modeling can be advantageous for identifying appropriate patients for clinical trials. Not only to look at variables that demonstrate that they're clinically eligible but also data variables to ensure you're reaching patients interested and motivated to participate in research. Since we launched this business, we've enrolled 18,000 patients into trials, and this success has primarily been driven by using RWD to inform patient targeting and site placement. RWD has also helped to inform the placement of our trial ready HealthHUBs. We use socioeconomic data, as one example, to tell where to place our site locations so that we're bringing clinical trials directly to those populations that are, traditionally, so poorly represented in trials.
MA: There also seems to be more of an interest in the biopharmaceutical industry regarding identifying gaps in therapy and care through RWE analysis. Can you speak more about that?
JP: We're working in the cardiovascular space to that end. We are developing prospective studies, where we reach out to those 100 million lives in our database and ask them if they want to participate in research studies. This allows us to interact directly with patients and collect information on why they are not seeking treatment. We’ve found that we can identify the gaps in their understanding of the disease, where they need assistance, or where there are opportunities to bring them treatments they may not be seeking. That could be helping a population access an already approved drug or helping pharma identify a population for which the available therapies aren't appropriate. Then we would work with our partners to bring something new to address that need.