CVS's Closure of Its Clinical Trial Unit and What it Means for The Future

In this discussion with Craig Lipset, a recognized leader in the field of clinical trials, we delve into the recent closure of CVS's clinical trial unit. Lipset provides valuable insights into the complexities and challenges of managing clinical trials within a retail pharmacy setting. He examines CVS's decision in the broader context of the pharmaceutical industry, explores potential impacts, and speculates on alternative models that could shape the future of clinical trials.

Moe Alsumidaie: There's been substantial chatter regarding CVS's decision to close its clinical trial unit. Could you provide some insight into what could have possibly happened behind the scenes, given your extensive experience in the field?

Craig Lipset: Thanks, Moe. CVS is the largest healthcare company in the United States. Companies like CVS have high expectations for new business areas to be meaningful sources of revenue. Some have speculated that "trials were too hard," but CVS had hired very experienced leaders from CROs and pharma that were "eyes wide open" to the challenges of running studies. In fact, they had built a very respectable pipeline and had developed a positive reputation among sponsors for delivering quality. But most new providers of solutions for clinical trials take years before they can reach even $25 million to $50 million in revenue, and given CVS's interests and priorities in primary care, it seems clinical trials were not going to be able to compete for attention and support. There are many very talented clinical trial professionals that worked to make the trials business work with high quality at CVS, and this decision seems to be based solely on economics and priorities. For those of us who have worked in large corporations, we have seen no shortage of examples of C-suite decisions made despite things working well in the trenches.

MA: CVS's involvement in clinical trials isn't a first for retail pharmacies, is it?

CL: Correct, Moe. In fact, we can look back over the past decade. Way back at DPharm 2013, John Orloff presented on work his team at Novartis was doing with Walgreens to run vaccine trials in the store. In fact, at Pfizer, we had planned our follow-on to the REMOTE trial as one meant to run inside Walgreens. But the investment and commitment at the time were not substantial, and when other corporate priorities emerged, Walgreens backed away from trial conduct.

Some will also recall work that McKesson had also published in 2013 together with Ken Getz at Tufts, where they showed strong support for clinical trial enrollment supported by the pharmacist.

In truth, CVS activity in clinical trials pre-dated the pandemic. Many pharma had worked with CVS and other pharmacies to support patient recruitment based on pharmacy data, typically running letter-based campaigns to patients. The Aetna business inside CVS had a real-world data company called Healthagen that had also supported life sciences and research for years. CVS acquired Coram back in 2014, which included Coram's clinical trial business of offering home health visits for clinical trials. What was new was bringing these pieces together and working to enable study conduct inside the store. The closure of the clinical trials unit at CVS then represents a loss of not only new capabilities but also some capabilities that have served the industry well for years.

MA: It certainly sounds like a significant loss. However, the fact that CVS had successfully offered these services for years and still decided to close its clinical trial unit is somewhat puzzling. What do you think this means for the future?

CL: Following the CVS entry into trials, we have seen Walgreens and Walmart, and more recently, Kroger and others take an interest in clinical trials. Some have worried that the CVS exit will lead to others backing away. I do not share this concern. Each has different strategies – some are more focused just on recruitment, which is more accessible. Others, such as Walgreens, have positioned clinical trials as a health equity priority, which may give them more flexibility to make an impact over time.

MA: Decentralized Clinical Trials (DCTs) are essential, given FDA's new guidance, and retail pharmacies seemed like an ideal platform for expansion and diversity. In your opinion, which other organizations are suited for this model?

CL: I am very keen to see if and when companies such as LabCorp and Quest consider entering their patient service centers as locations for study conduct. They are more focused on clinical services than typical retail locations and often embedded in communities, and they have waiting rooms and people in white coats rather than mixing trials in a traditional retail setting. Retail will have its place for some, but more doors are needed. As we see increased use of video to enable the investigator to "see" their patients from other locations (labs, community physician offices), we will continue to see more locations unlocked for access.

MA: That's a fascinating outlook. So, you're envisioning a future for clinical trials that leans more towards unconventional sites and virtual interactions.

CL: First, we will still have a core focus on the clinical trial site as we know it today, just further supported and enhanced with decentralized tools that improve access. But we know our existing site capacity is not adequate to help ensure equitable access to research participation. And so, we will still need other stakeholders – pharmacy, labs, and mobile units. The FDA draft guidance on DCT also takes an important step to define new roles for healthcare providers to support trials, and I am keen to see how we can unlock every doctor's office as a "host location" for a study investigator to see a participant powered by video.

MA: Let's shift gears a bit and talk about the impact of CVS's decision on patients. How do you think this closure might affect them? And how would this shift towards organizations like LabCorp or Quest impact patient experience?

CL: It is my understanding that CVS is continuing to support sponsors with studies enrolling patients in the near term and for longer studies that are ensuring patients are migrated to an appropriate site. Ideally, no patient should feel cut off or abandoned if they were engaged in a trial through CVS. But this is certainly a lost opportunity going forward, as CVS has a substantial footprint to have helped inform patients about research opportunities going forward. That said, this certainly leaves even more room in the market for others – whether pharmacies like Walgreens, Walmart, and Kroger, labs like LabCorp and Quest, or others.

MA: Indeed, patient-centricity is key. Lastly, Craig, given all these developments and potential shifts, how should pharmaceutical companies position themselves to adapt?

CL: Many pharma sponsors invest time and energy to engage with innovative new partners. Whether through executives in development operations or clinical operations or through dedicated "clinical innovation teams," tracking and engaging a partner can take substantial effort. It can be defeating when a team has identified and engaged a partner like CVS, including the effort to build support and advocacy among leaders and other lines within their company. This is a reminder for pharma sponsors of the importance of resilience and agility. Momentum begun with a partner like CVS can be sustained with new partners, and teams have to remain agile to flex and adapt when changes such as these take place.

Our current models for research are unsustainable, and for too many people, they are inaccessible. Investments to make trials more patient-friendly, more accessible, and more digitally enabled are the right direction for the near term and the long term.