Experts in the biopharmaceutical industry have discussed the numerous advantages of patient recruitment in pharmacy settings; for example, 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 leveraging its existing infrastructure to bring clinical trials to the patient by conducting them in public spaces, closer to patients’ homes. CVS Health also supports clinical trials through targeted recruitment efforts and the generation and analysis of real-world evidence that can be used to optimize trials and identify gaps in care. In this interview, Jill Pellegrino, Vice President of Recruiting and RWE at CVS Health® Clinical Trial ServicesTM, will discuss this infrastructure and why CVS Health entered the world of clinical trials.
Moe Alsumidaie: CVS Health launches Clinical Trial Services in May 2021. How did this business come about?
Jill Pellegrino: CVS Health has been involved in clinical trials for many years. We officially launched clinical trial services after CVS Health collaborated with the pharmaceutical industry to facilitate clinical trials for investigational vaccines and treatments against COVID-19. During that time, we’ve engaged more than 300,000 volunteers and helped connect them to local studies. From this initial success, it became clear that there was an unmet need for access to clinical trials that CVS Health could uniquely address. This is really where the business concept is born. Since then, we have done a lot of work outside of COVID-19, including trials with over 20 sponsors in ten therapeutic areas.
MA: In 2012, I discussed with Walgreens and CVS the potential of enrolling patients in clinical trials; they entertained the idea but did not pursue it at the time. Why is now the right time to do this?
JP: The pandemic has highlighted the significant need to conduct trials 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 several ways to do this. First, across our enterprise, we have access to a population of one hundred million people from all of our businesses: our retail pharmacies, Aetna Health Plan and MinuteClinics. Our relationship with this population allows us to present relevant clinical trial opportunities directly to them. The second area is increasing access to clinical trials in 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 home trial capabilities make it easy for people to participate in clinical research.
MA: Pharmacies are evolving from a place to distribute products to a healthcare destination. How does this trend affect CVS Health and clinical trials?
JP: There is a growing desire to use the pharmacy as a healthcare 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 it from their pharmacy. We conducted a survey with over 2,000 customers who responded. 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 rather hear about clinical trials from a pharmacist than from their doctor. People want to participate in trials and see the pharmacy as a reliable partner to help introduce them to trials.
MA: Can you tell me more about drug dispensing and having researchers at the CVS Health site? How does this model work?
JP: We have built and continue to develop a site model using our MinuteClinic infrastructure. CVS Health operates HealthHUBs MinuteClinics that offer broader healthcare services that can support clinical trials. Of these HealthHUBs, 80 are considered trial-ready, meaning they are staffed with trained nurses, study coordinators and clinical specialists to conduct trials at these sites. We are also expanding our network of investigators to facilitate trials at our locations. These experienced researchers have done clinical research in their practices and can work virtually or at our locations. Working with CVS Health can expand their reach and access to patients. In terms of therapeutic areas, we initially focus on vaccines, infectious diseases, metabolic, cardiovascular, pulmonology, dermatology, oncology, neurology and immunology/autoimmune.
MA: How does CVS Health recruit patients for clinical trials?
JP: Our goal is to offer trials that are most relevant to our customers in their healthcare journey. We recruit patients from our CVS Health population for studies we conduct at our HealthHUBs and at other investigator sites. In both cases, we first work with the trial sponsor to understand their protocol and patient criteria. We then go to our database to identify those who might qualify for the trial and send them an invitation to participate. If accepted, the patient is directed to a research site or one of our HealthHUB locations. We are very careful about patient privacy. We always ensure that we protect our patients’ information and do not share any health data with pharmaceutical companies or researchers without the patient’s consent.
MA: How do you expect the existing study sites to respond as CVS Health begins to grow into clinical trials?
JP: We have had positive reception from the clinical sites; our ability to find patients and use our centers for patient visits or tests is welcome. CVS Health can be a strong partner for traditional clinical centers.
MA: So instead of traveling to the site, if the patient lives far away, they can go to a local CVS pharmacy to get blood drawn or get their medication refilled?
JP: Yes exactly. This type of model increases patient participation because it is easier for them. In addition to local CVS Health locations, we also integrate telemedicine and home nursing capabilities so they can make specific tests and visits from the comfort of their own home.
MA: How do you leverage 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, such as a clinical trial. RWE can be used in many ways. It can be used to better understand long-term health and safety outcomes. It can be used to understand the effectiveness and efficiency of treatment or the behavior of the patient and doctor.
We see most countries relying on real-world data extracted from medical records such as claims or EML, EMR and EHR systems. CVS Health is uniquely able to gather deeper insights that may not be found in medical records alone. This helps clarify patient behaviour, perceptions and any limitations they have such as cost or knowledge. These insights have implications for both the use and effectiveness of treatment. For example, we regularly enter data on social determinants of health to complement our patients’ clinical data. We find this informative in helping us and our pharmaceutical partners understand various variables that could affect select patient groups’ ability to seek treatment.
MA: How can RWD be used in clinical trials?
JP: We think there is a huge opportunity to use RWD beforehand in clinical trials. We found that data modeling can be useful for identifying suitable patients for clinical trials. Not only to look at variables that demonstrate they are clinically admissible, but also data variables to make sure you are reaching patients interested and motivated to participate in the study. Since we launched this business, we have enrolled 18,000 patients in trials and this success is largely due to the use of RWD to inform patient referral and site placement. RWD also helped inform the placement of our HealthHUBs ready for trial. We use socioeconomic data, as one example, to tell where to put our site locations so that we deliver clinical trials directly to these populations that have traditionally been so underrepresented in trials.
MA: Also, there seems to be more interest in the biopharmaceutical industry in terms of identifying gaps in therapy and care through RWE analysis. Can you talk more about that?
JP: We are working in the cardiovascular space for this purpose. We develop 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 gather information about why they are not seeking treatment. We found we could identify gaps in their understanding of the disease, where they needed help, or where there were opportunities to offer them treatment they might not have sought. This can help a population gain access to an already approved drug or help pharma identify a population for which available therapies are not suitable. We will then work with our partners to bring something new to meet that need.