Moe Alsumidaie

Decentralized clinical trials (DCTs) are revolutionizing the research landscape by bringing trials directly to patients, enhancing accessibility. A potential key player in this transformation is the retail pharmacy industry. Despite recent developments, such as the closure of CVS Health's clinical trials unit, it's not yet over for retail pharmacies in clinical trials. With their extensive network and infrastructure, retail pharmacies like Walmart, Kroger, and Walgreens can significantly improve patient access to clinical trials. This article will discuss how these retail pharmacies can harness their resources to promote diversity and inclusion, enhance patient accessibility, embrace technology for virtual care, and prioritize patients in clinical trials. By adopting a more patient-centric approach and adhering to FDA's guidance on DCTs, retail pharmacies can contribute to a more inclusive and accessible clinical trial landscape, proving that the potential of retail pharmacies in clinical trials is far from exhausted.

Decentralizing clinical trials through retail pharmacies

Retail pharmacies can serve as decentralized sites for clinical trials, making participation more convenient for patients. FDA guidance recommends using local healthcare providers for more accessible assessment and monitoring of trial participants, which can be facilitated through retail pharmacies' existing infrastructure. For example, Walmart operates over 4,700 stores across the US, with a majority of Americans living within 10 miles of a Walmart store. By using retail pharmacy networks to facilitate patient enrollment and participation in DCTs, patients can access trials more conveniently, reducing the need for long-distance travel and improving patient retention.

Promoting diversity and inclusion through retail pharmacies

Promoting diversity and inclusion is another critical aspect of the clinical trials industry. FDA emphasizes the need for diverse patient representation in clinical trials to ensure trial outcomes apply to a broader population. Retail pharmacies can collaborate on initiatives encouraging diverse patient representation, leading to more comprehensive and relevant research outcomes.

Enhancing patient accessibility through retail pharmacies

Retail pharmacies can make clinical trials more accessible to a wider range of people, particularly regarding minority representation. FDA guidance recommends using electronic informed consent (eConsent) in DCTs to facilitate informed decision-making by trial participants while ensuring the process complies with regulatory requirements. Retail pharmacies can provide the necessary infrastructure for eConsent, making it more convenient for patients to participate in trials.

Embracing technology for virtual care in retail pharmacies

Retail pharmacies can leverage technology to facilitate remote monitoring, data collection, and communication between patients and researchers. FDA guidance underscores the importance of eClinical technologies in managing various trial-related activities. Retail pharmacies, such as Walgreens, can leverage existing virtual care assets, which can help streamline the DCT process and make it more efficient.

Retail pharmacies can play a pivotal role in adopting a patient-first approach by enhancing the patient experience and reducing participant burden. They can provide patients with easy-to-understand information about the trial, its risks, and its benefits. They can also leverage eConsent by providing patients with engaging resources such as videos or educational materials to help them make informed decisions about participation.

The case of CVS: A lesson, not a conclusion

The recent closure of CVS Health's clinical trials unit serves as a lesson for other retail pharmacies considering venturing into the clinical trials industry. The decision could have been attributed to various factors, including strategic realignment, competition, operational hurdles, financial implications, and industry trends. However, this should not be seen as a conclusion that retail pharmacies cannot succeed in clinical trials. Instead, it should serve as a reminder that careful evaluation of strategic fit, competition, infrastructure, financial constraints, and industry trends is crucial when venturing into new market areas.

The path forward: It's not over for retail pharmacies in clinical trials

Despite the challenges, it's not yet over for retail pharmacies in clinical trials. The increasing demand for DCTs and the apparent growth of the clinical research sector present an opportunity for retail pharmacies to redefine their role in healthcare and contribute to the advancement of clinical research. Retail pharmacies can leverage their extensive networks, established infrastructure, and technological capabilities to improve patient access, promote diversity and inclusion, and support clinical trial expansion into minority communities.

FDA's guidance on decentralized clinical trials emphasizes the importance of incorporating technology and innovative approaches to make clinical trials more patient-centric and efficient. Retail pharmacies are uniquely positioned to support these efforts, particularly when it comes to virtual care.

The key to success lies in a long-term commitment to clinical research, significant investment in infrastructure and training, and a patient-centric approach. Retail pharmacies need to balance their core business operations with the rigorous requirements of clinical trials. They must also be prepared to face competition from traditional clinical trial sites, such as hospitals and academic medical centers with established infrastructures and specialized equipment.

In conclusion, the closure of CVS's clinical trials unit should not be seen as a sign that retail pharmacies cannot succeed in the clinical trials industry. Instead, it should serve as a reminder of the challenges of venturing into new market areas. With careful planning, strategic investment, and a patient-centric approach, retail pharmacies can make clinical trials more inclusive and accessible. As the clinical trials industry continues to evolve, it is essential to prioritize inclusivity and accessibility to ensure that all patients have the opportunity to participate in research that can improve their health and well-being. By working together, researchers, healthcare providers, and retail pharmacies can make this vision a reality.

, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and regular contributor to Applied Clinical Trials.

Articles

How retail pharmacies can harness their resources to improve clinical trial access.

Retail Pharmacies and Decentralized Clinical Trials: The Path Forward Despite Challenges

With CVS exiting the clinical trials arena through its clinical trials unit closure, other retailers are continuing to pursue clinical trials. In this interview, we're joined by Jim Kirby, Chief Commercial Officer at Kroger Health, to shed light on Kroger's groundbreaking entry into the clinical trials arena. Kirby provides valuable insights into Kroger's collaborative approach, commitment to diversity, and dedication to ensuring the success of their clinical trials unit. 

Moe Alsumidaie: Could you elaborate on the collaborative approach Kroger is adopting in relation to the clinical trials arena?

 At Kroger Health, we firmly believe in the power of collaboration, especially in a field as expansive and nuanced as clinical trials. Our strategy relies heavily on working hand in hand with the local ecosystem. We recognize that each local institution is an expert in its field, and we want to create an environment where they feel part of the Kroger team and together we are working toward the same goals. We strive to build on existing relationships with health systems, payers, non-profits, and other stakeholders within the communities we serve. We see tremendous value in working together to boost community involvement in clinical trials.

MA: Are there any key insights or lessons you've garnered from other retail health pharmacies operating in the clinical trial sector? How are these insights shaping Kroger's strategy in this domain?

 Regarding strategy, our main priority is quality. We want to ensure that we can do exactly what we say we can, and part of that is our commitment to enrolling patients from diverse backgrounds. We must incorporate the diversity of the local communities we serve in our trials, which means engaging with individuals who have not traditionally been part of the clinical trial process. Because our involvement in the clinical trials space is new, our perspective and tools will also seek to evolve and enhance over time.

MA: With the need for more local diversity and inclusivity in clinical trials increasingly acknowledged, how does Kroger plan to ensure the representation of minorities and underserved communities in your trials?

 The need for increased diversity and representation in clinical trials is an issue we're very much attuned to at Kroger. In fact, one of our key strategic goals is to enroll patients from various backgrounds, ensuring our trials reflect the diversity of the communities we serve. This includes reaching out to those traditionally underserved in clinical trials. As a retailer trusted by many in these communities, we're uniquely positioned to build upon this trust and engage these populations effectively. We will be working with local community boards, non-profits, and health systems to enhance our outreach and engagement efforts and create an environment where diverse participation in clinical trials is not just possible but encouraged. Our ultimate goal is to make clinical trials accessible and beneficial to everyone, regardless of race, ethnicity, or socioeconomic background.

MA: Can you speak a bit more about Kroger's financial commitment and long-term investment in ensuring the clinical trials unit at Kroger is successful over time?

As you can imagine, launching a clinical trials unit is a substantial undertaking that requires significant investment. We're making initial investments to get our clinical trials off the ground and learn from early pilot projects. We're staffing up for these experiences and continuously evaluating our processes to understand where we need to invest further, whether it's in technology or human resources. Once we have concrete insights from these pilots, we'll be better equipped to decide the next investment stage needed to scale our efforts effectively.

MA: Given the FDA's recent push toward decentralizing clinical trials, how does Kroger plan to align with this trend?

 We aim to use digital health technologies to facilitate a decentralized approach, enabling us to reach more patients while maintaining the high quality of our clinical trials. Moreover, we're engaging local healthcare providers and research teams in quality assessments, crucial for ensuring patient safety and data integrity.

MA: Can you give us an idea of the therapeutic areas you plan to focus on? How can Kroger's capabilities as a retail pharmacy be applied to these areas?

As a retail pharmacy with a strong focus on healthcare, we're setting our sights on primary care, internal medicine, and chronic disease states, which include conditions like heart failure, diabetes, cardiovascular disease, pulmonary diseases, and mental health issues. These are conditions typically treated in a primary care setting. We are also particularly interested in preventive health, including vaccinations and nutrition. That being said, we're conscious of our limitations. For example, we likely won't engage with infusible drugs or rare diseases at community pharmacies. However, we're keenly interested in medical devices as they often transcend a single therapy.

MA: How does Kroger's principal investigator (PI) oversight infrastructure ensure that patients are safe and that data quality is uncompromised?

 Ensuring patient safety and data quality is at the heart of everything we do at Kroger Health. The PI works closely with the nurse practitioners and sub-investigators at our clinic locations, providing comprehensive oversight. They communicate regularly, ensuring alignment and coordination. When it comes to the patients we've enrolled, our PI is thoroughly involved in all elements of the conduct of the trial. We're taking a very methodical approach to this, going above and beyond the requirements to ensure we don't compromise on patient safety and data quality.

MA: Are there any key takeaways or insights you would like to share about Kroger's efforts in clinical trials?

The major takeaway from our efforts so far is that successful clinical trials require robust and thorough recruitment and enrollment processes and equally thorough strategies for retaining participants. We have a unique opportunity to make a real difference with Kroger Health and our community-focused health locations. Many of these communities haven't traditionally had access to clinical trial opportunities, and by giving them this access, we're fostering a completely different level of trust than that found in major academic institutions. With 90% of the U.S. population living within five miles of a pharmacy, and 51% of all Kroger stores located in what would be considered socially vulnerable areas, our clinical trial sites are poised to open the doors to patient cohorts that did not have access to clinical trials previously. This proximity and trust will increase our clinical trials' enrollment and retention success rate. It's all about serving and benefiting the community.

Staying the Course: Kroger Continues to Impact the Clinical Trials Landscape

In this discussion with Craig Lipset, a recognized leader in the field of clinical trials, we delve into the recent closure of 

. 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?

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?

: 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?

 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?

 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.

 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?

 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?

 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.

In this Q&A, Craig Lipset offers additional insights following the announcement that CVS will be closing its clinical trial services business by the end of the year. 

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

While many big pharma companies have shied away from the cardiovascular space, and even fewer smaller biotechs are venturing into it, NewAmsterdam Pharma stands as a notable exception. In this interview, John Kastelein, MD, founder and chief scientific officer, delves deep into the challenges and opportunities within the cardiovascular field, exploring the current landscape for lipid-lowering therapies and the unique potential advantages of CETP inhibitors. The conversation covers various aspects of clinical trial design, emphasizes the importance of diversity and inclusion in trial enrollment, and reflects on lessons learned from the COVID-19 pandemic. Additionally, Kastelein shares his perspective on why the company has chosen to invest in its own Phase III trials instead of pursuing acquisition.

Moe Alsumidaie: Given the global concern for cardiovascular health and the crisis driven by factors like obesity, why are relatively few biopharmaceutical companies working in this space?

 The rising rates of cardiovascular disease and death in the US can be partly attributed to therapeutic inertia, where patients and doctors struggle to adhere to and implement guidelines. Expensive new drugs, such as monoclonal antibodies to PCSK9, and inexpensive but less potent generics like ezetimibe have left little room for new development. Also, companies find it difficult to introduce drugs that offer significant benefits over existing generics to justify payers to cover the costs.

MA: Can the success seen in the diabetes space, with many new medications and no therapeutic inertia, be replicated for blood pressure and lipid management?

 Yes, it should be possible for blood pressure and lipid management, but we still need to see that happen. We believe that obicetrapib, our CETP inhibitor, has the potential to partly address some of the questions in the lipid space.

MA: With your extensive experience in cardiovascular studies, can you explain how trial designs have evolved to generate better outcomes compared to the past?

. The major change is that new drugs must be tested on top of statin therapy. However, some mistakes have been made in the past that can be corrected now. For instance, cardiovascular outcomes trials need to last at least four years for lipid lowering to see significant changes in endpoints.

MA: What barriers do you face as a small company trying to enter the cardiovascular space?

 One of the main challenges for investors and small companies is the cost of clinical trials. FDA requires large Phase III lipid programs and outcomes trials, making the costs quite significant. However, we are committed to approving our drug. We believe our current cash balance will be sufficient to fund our operations through the expected completion of our ongoing trials and demonstrate that our drug lowers cholesterol and reduces heart attacks and strokes.

MA: Smaller pharma companies usually pursue acquisition rather than investing in their own Phase III trials. Why did you choose the latter?

 We chose to invest in our own Phase III trials because we believe the true value of our compound will only become apparent after the completion of the two lipid-lowering Phase III trials. We believe our drug has unique properties, with potential benefits in diabetes, Alzheimer's, and other conditions, along with its potent LDL-lowering capability. We think that the full potential of our drug can only be appreciated after large-scale trials that demonstrate its efficacy and safety. Our management team has extensive experience in this area, which gives us confidence in our ability to successfully execute the trials ourselves and maximize the value of our compound.

MA: Considering the current landscape for lipid-lowering therapies, what unique benefits does the CETP inhibitor offer that would justify its inclusion in payer formularies and differentiate itself from existing therapies in the market like the SGLT2 inhibitors?

 Our CETP inhibitor is very potent at a low dose of 10 milligrams, making it appealing for our target demographic with a mean age of 70. Additionally, our drug has been generally well tolerated in clinical trials to date, is cost-effective to produce, and is designed to be taken as a small tablet once a day. We have learned from past challenges in trial design and have taken great care in designing our Phase III program and our cardiovascular outcomes trial differently, hopefully ensuring its success.

MA: What unique benefits does the CETP inhibitor offer compared to existing therapies like SGLT2 inhibitors?

 Our CETP inhibitor has several advantages. It is very potent at a low dose of 10 milligrams. In our ROSE Phase IIb trial, patients receiving our CETP inhibitor at 10 mg showed a median reduction of LDL-C of 51% versus baseline in patients who were on a high-intensity statin therapy. When given the CETP inhibitor at 10 mg in combination with ezetimibe in the ROSE2 trial, we saw even greater reductions in that population. These data are appealing for our target demographic, who are mainly elderly people. The small pill is convenient for daily use and can be taken with or without food. Additionally, the drug is inexpensive to produce, which allows for flexible pricing attractive to payers. Furthermore, we plan to study the CETP inhibitor’s protective effects against diabetes and possibly also against Alzheimer’s disease. This range of potential benefits makes it a promising option for patients.

MA: How have you ensured your clinical trials last long enough and target high-risk patients? How has the COVID-19 pandemic influenced your trial designs?

 We have stipulated that our outcomes trials should last at least 2.5 years after the last patient enrolls, totaling about 4 years. To enrich our trials, we have selected patients with conditions such as elevated triglycerides, diabetes, and recent coronary disease. During the pandemic, we were also able to address underrepresented communities, such as African Americans and other demographics in our trials, achieving our intended diversity goals. Conducting cardiovascular outcomes trials during the pandemic was challenging for the industry, but fortunately, the bulk of NewAmsterdam’s ongoing outcomes trial has taken place after the worst of the pandemic.

In this Q&A, John Kastelein, MD, founder and chief scientific officer, NewAmsterdam Pharma, discusses the challenges and opportunities within the cardiovascular field, exploring the current landscape for lipid-lowering therapies and the unique potential advantages of CETP inhibitors. 

Breaking New Ground in Cardiovascular Health: Innovative Approaches in Clinical Trial Design

The recent announcement from CVS Health about the closure of its clinical trials unit, initiated only two years ago during the COVID-19 pandemic, has ignited a flurry of speculation. The move, seemingly counterintuitive given the unit’s launch at a critical juncture in the healthcare industry, has prompted a deeper examination of possible reasons behind this decision. In this analysis, we delve into various factors that could potentially have influenced CVS’s decision, including the aspects of strategic realignment, financial performance, competitive dynamics, and operational difficulties amidst the backdrop of ongoing industry-wide layoffs. It’s important to note that these are speculative interpretations based on available information.

CVS Health, while best known for its retail pharmacies, is a complex organization with diverse operations, including an insurance unit (Aetna) and a pharmacy benefit management (Caremark) company. One reason behind the company’s decision to exit the clinical trials business could be a desire to realign and focus on its core business. In their statement, CVS indicated their ongoing evaluation of the company’s asset portfolio to ensure alignment with long-term strategic priorities. The decision to wind down the clinical trials unit suggests it may not have been a strategic fit for the company’s broader vision.

One contributing factor to CVS’s exit from the clinical trials industry could be the significant competition posed by traditional clinical trial sites, such as hospitals, academic medical centers, and even independent sites, which boast established infrastructures, specialized equipment, experienced staff, and robust procedures for managing complex clinical trials. Despite CVS’s extensive physical network and broad customer base, its primary competencies as a retail pharmacy might not align seamlessly with the rigorous requirements of sponsors. While CVS’s expansive retail network and broad customer base are well-suited for conducting simple studies, such as vaccine trials, its infrastructure might not be equipped to handle more complex trials. For instance, trials in areas like central nervous system (CNS) disorders or other specialized disease indications often require advanced equipment, highly trained raters, and intensive patient monitoring, all of which may exceed the capabilities of a typical retail pharmacy setup. This could have posed significant logistical challenges and might have hindered CVS’s ability to compete effectively with hospitals, academic medical centers, and other traditional trial sites that already possess the requisite infrastructure and expertise for such complex studies. This infrastructural mismatch and the competitive landscape may have potentially prevented the growth necessary to keep CVS’s clinical trials business operational.

Gaining a foothold in the clinical research industry is a long-term commitment that requires significant time, resources, and patience to truly gain traction. Unlike other business sectors, the outcomes and returns in clinical research are often not immediately quantifiable, making it a challenging environment for public companies like CVS that are accountable to shareholders and must regularly demonstrate growth and profitability in their core business (which isn’t clinical research). Shareholders often focus on hard numbers, such as revenue growth, profit margins, and return on investment, all of which must be clearly and regularly reported in financial statements, and may not be as patient with the longer-term, less predictable returns that come from a new venture like clinical research. For example, establishing a successful clinical trial program often involves substantial upfront investments in infrastructure, personnel, training, and relationship-building with sponsors, with the return on investment only realized years later. This focus on immediate, financially quantifiable results could have contributed to CVS’s decision to exit the clinical trials business.

While the demand for DCTs has risen dramatically in the wake of the COVID-19 pandemic, it seems this shift hasn’t been enough to secure the success of CVS’s clinical trial unit. Despite the increasing popularity of DCTs, driven by the need to reduce COVID-19 exposure risk, enhance patient convenience, and improve trial efficiency, this demand did not translate into a sustainable model for CVS. According to a survey by Veeva Systems, 87% of sponsors and CROs intend to employ DCTs, a leap from a mere 28% pre-pandemic. The belief that DCTs improve patient convenience and retention was shared by 56% of these stakeholders. Benefits of DCTs, such as increased patient convenience, reduced trial costs, improved efficiency, and greater inclusion of diverse patient populations, have been widely recognized. Despite this growing demand and the apparent fit with CVS’s extensive retail footprint, the company’s clinical trial business didn’t prosper as expected.

The closure of CVS’s clinical trials unit signifies a broader trend in the biotech and pharmaceutical sectors, characterized by escalating job losses due to high drug development costs and intense industry competition. Over 5,000 layoffs have occurred this year in the biotech industry, more than in previous years, as reported by BioPharma Dive. Individuals affected by these job cuts face financial hardship and difficulties finding new employment while the industry grapples with declining morale and challenges in attracting and retaining talent. The decision by CVS to shut down its clinical trials may also impact the personnel it hired from the biopharmaceutical industry, also contributing to the overall layoff industry trend.

In conclusion, the decision of CVS Health to shutter its clinical trials unit can be attributed to a confluence of potential factors such as strategic realignment, competition, operational hurdles, financial implications, and industry trends. Despite the increasing demand for DCTs and the apparent growth of the clinical research sector, the company’s exit is a testament to this industry’s intricate and challenging landscape. CVS’s refocus on core business areas potentially highlights the tough choices businesses have to make in response to a constantly evolving healthcare environment – a fate other retail pharmacies, such as Kroger, Walgreens, and Walmart, may face. The journey of CVS Health’s clinical trials unit serves as a speculative case study, reminding us that venturing into new market areas, even for established companies, necessitates a careful evaluation of strategic fit, competition, infrastructure, financial constraints, and industry trends.

The views expressed in this article are the author's. 

The journey of CVS Health’s clinical trials unit serves as a speculative case study, reminding us that venturing into new market areas, even for established companies, necessitates a careful evaluation of strategic fit, competition, infrastructure, financial constraints, and industry trends.



Why Did CVS Shutter its Clinical Trials Unit?

In a recent interview, Tiffany Chow, MD, a specialist in behavioral neurology and senior medical director at Alector, discusses the unique challenges of designing clinical trials for frontotemporal dementia (FTD), a type of dementia that typically affects individuals in mid-life and can have a severe impact on their financial security and quality of family life. Chow highlights the underdiagnosis of FTD, the need to raise public awareness of the disease, and the potential role of genetic testing and counseling in FTD diagnosis and treatment. She also emphasizes the importance of supporting patients and their families as clinical trials for FTD progress and expresses optimism for the future of FTD research.

Moe Alsumidaie: Can you talk to me about how FTD differs from Alzheimer’s, and can you discuss some of the challenges in designing trials for potential treatments that are effective for dementia patients?

There are many causes of dementia, and Alzheimer's disease (AD) is highly prevalent around the world for people over the age of 65, with the average onset usually in the 70s. FTD, or frontotemporal dementia, on the other hand, usually has its onset when an individual is actively parenting, holding a job, and raising children. Additionally, there are genetic and nongenetic forms of FTD, the former typically being the cause of one of three types of gene mutations. In these ways, the impact of FTD on the patients’ financial security and quality of family life can be severe, not to mention the larger impact on the family.

When designing a trial for this population with marked changes in baseline personality, motivation and organizational skills, there are many important considerations. At Alector, we’re committed to understanding these unique challenges and have clinical trials in Phase II and Phase III for FTD. We have found that FTD is underdiagnosed out in the general population. It behooves us to make sure that our primary care physicians and general psychiatrists consider FTD before the much less common abrupt mid-life onset of bipolar affective disorder or attention deficit disorder. Alternatively, behavioral changes may fool families into thinking a 50–60-year-old is having a “midlife crisis” or a reaction to early retirement, which can delay seeking medical attention and an accurate FTD diagnosis by years. As awareness of FTD increases and when disease-modifying therapies become available, patients may be more likely to seek medical attention sooner. There might also be a boost in interest to pursue genetic testing, if therapies are specific to mutations that cause FTD.

As a specialist in behavioral neurology, I’ve had family members relieved to have an explanation for drastic changes in social skills and abilities at home and at work that haven’t fit typical depression or obsessive-compulsive disorder. It helps them to offset the tragedy of knowing they are facing a neurodegenerative disorder.

MA: You talked about FTD being so underdiagnosed. Because it is so underdiagnosed among patients, I would imagine education around FTD itself and how it differs from Alzheimer’s disease would be paramount in getting patients to participate in a clinical trial?

 Enhancing public awareness of FTD can help us combat that challenge of underdiagnosis, especially when you consider that FTD is not as common as AD. Because current clinical trials are focusing on specific genetic mutations causing the FTD syndrome, we need to cast a wide net, first to find as many FTD patients that exist and need appropriate medical support and to help patients understand which clinical trials they may enter. We need both the general public and primary care physicians to think of FTD in middle-aged persons who are having such 180-degree turnarounds in the way they conduct themselves professionally and socially. And we need to seek these patients out globally, not just in one country.

After a correct diagnosis is made, and the patient is informed whether there is a genetic mutation for which there is a therapy, the next hurdle may be the symptoms of their FTD. Difficulty with concentration and hyperactivity may make it hard for them and their families to participate in the activities that a clinical trial entails, such as regular travel for evaluations that may be more frequent than their routine doctor visits, being able to lie still for brain scans, being able to give blood and urine for labs, especially when the lack of insight about one’s own dementia makes it hard to understand why so many doctor visits are necessary. Family members may have to choose to save arguing for basic safety needs, such as keeping the patient from driving illegally. I have had to go down to the parking lot to evaluate a patient in the passenger seat of the family car, because she refused to come into the building.And as I started to mention, partners without FTD are working full-time themselves, perhaps as now the single income source for the household, and actively parenting young children or teenagers. In FTD, you have the difficulty of fitting it into a full and active life, but also there's the dire motivation to try something to stop this illness. Families are really doing the best that they can to manage this awful condition and there is no approved disease modifying therapy to stop the progression of FTD, which moves more quickly than AD.

MA: Tell me more about genetic testing, which sounds like it might potentially open the door for study participation among patients living with FTD?

 There may be several barriers to getting genetic testing. Patients and families may be wary of learning about a difficult future living with the risk of a dementia diagnosis that doesn’t have an approved therapy yet. Once there is a dementia diagnosis, we find that patients and families wanting to know more, including the genetics that may be contributing.

However, implications of positive genetic testing are daunting. For example, patient advocacy groups are working to preserve the confidentiality of genetic mutation status, but these are real concerns. Another barrier is the accessibility of getting genetic counseling and then testing. Historically, physicians will only suggest genetic testing if there is a strong family history of first-degree relatives (e.g., father, brother) who manifested the same illness. This works when the condition always presents the same way and can be readily diagnosed, but we found in our work in the 1990’s that for FTD, primary psychiatric diagnoses such as bipolar affective disorder must be included on the list of significant family history. We’re still learning whether the genetic mutations do cause a range of conditions outside of FTD or if those earlier generations were misdiagnosed! For this reason, asking for a family history as a criterion for going to genetic testing may not be adequate.

MA: Can you explain to me about the prospect of genetic counseling as a pre-cursor to genetic testing when it comes to FTD?

 I consider genetic counseling to be very important. Families need support in important decision-making, in terms of when genetic testing should be done, who will learn the results, and with whom the patient will want to share the results. Genetic counselors manage expectations and help to prevent undesired reporting outcomes for patients and family members who may be at risk for developing FTD later themselves.

MA: Talk to me a bit about what advancements in the treatment of other neurological diseases mean for the FTD treatment landscape and for the future of clinical trials in the space?

 One benefit of the progress that has been made in Alzheimer’s disease is the optimism and hope that has been offered, to stop Alzheimer's disease before it ruins our golden years. This is terrific, and it motivates people to get evaluated, whether they have early changes that count as mild cognitive impairment, or a later stage already diagnosed with dementia due to AD.

FTD affects fewer people, but it can cause much more collateral damage than AD in the workplace, in the home and in the community. As a society, we should also be thinking about how we can best support the patients and their families. They might need resources and support in getting the patient taken care of, keeping the family safe and healthy, and fostering the family’s growth and development. I think the more attention paid to how we can support the patients and families, the more we will meaningfully help everybody. This is an exciting time to watch for progress in clinical trials in FTD, and I must admit I wasn’t sure this would happen during my career, but I am proud to be part of Alector’s clinical program in FTD.

Tiffany Chow, MD, a specialist in behavioral neurology and senior medical director at Alector, discusses the unique challenges of designing clinical trials for frontotemporal dementia.