Local pharmacies and big-box stores are no longer just purveyors of deodorant, prescriptions and laundry detergent; many have crossed the line into healthcare providers — offering everything from flu vaccines to primary care checkups. These highly trafficked neighborhood retailers have been building healthcare delivery capabilities at more than 2,000 locations nationwide, aligning to changing patient preferences and answering the call of consumers who want care at more convenient locations.
This shift for retailers and the disruption to conducting clinical trials at academic medical centers and hospitals by COVID-19 has given the biopharma industry an opportunity to significantly accelerate alternative clinical trial delivery approaches, such as local, at home and virtual options. Leveraging the scale, reach and capabilities of national retail health clinics and physician practices is helping to transform an antiquated clinical trial model and address the weaknesses of traditional trials that were exposed by shutdowns during the pandemic.
Tapping into local markets
Decentralized trials — which are designed, planned and executed using a combination of delivery channels — are seen as a way to reduce operational complexities, cycle times, costs and patient burden. In addition, decentralized trials can open access to more diverse patient populations, bolstering enrollment and offering increased flexibility that reduces patient burden and improves retention.
For instance, pharma companies open an average of 94 sites per Phase III trial, according to Citeline1. Traditionally, clinical trials take place across a large number of small, fragmented sites, making it difficult to effectively plan, deliver and manage clinical trials. Alternatively, new entrants could offer a large number of locations that are operated as a single megasite, providing companies with large national partners that are convenient to patients. The future model could bring the total number of sites down from the current average of 94 to as few as 10 on a typical Phase III trial, providing a hub-and-spoke model with better geographic coverage, as well as enterprise-level compliance and quality monitoring.
New entrants — like national retail pharmacies, retail health clinics, physician practices and decentralized trial technology companies — have access to exponentially larger numbers of patients. PwC’s Health Research Institute found that 67% of consumers were less likely to participate in a clinical trial for COVID-19 treatment if they had to travel outside of their local area to a trial site.
Increased access to patients allows for the acceleration of recruitment and the ability to start up fully-scaled trial delivery capacity in days or weeks versus months. The convenience of location and increased access improves flexibility for patients, ultimately reducing the patient dropout rate.
1 source: TrialTrove, citeline.informa.com, accessed October, 2021
50% of FDA clinical trials in the US are conducted in only 1-2% of zip codes
A new prescription for care
National retail health clinics and community practices such as CVS HealthHUB, Walmart Care Clinic and Kroger’s The Little Clinic are likely players whose existing infrastructure could be leveraged to play a critical role in the next-generation clinical development models currently being established. These large players will catalyze a decentralized, “omnichannel” approach that integrates hospitals, at-home services, virtual/technology aspects and local providers and clinics.
These new entrants are rapidly expanding their healthcare service capabilities and capacity. For instance, CVS has begun to convert retail locations into HealthHUB formats that include a broad range of healthcare services. CVS, which has the largest retail clinic presence in the US, plans to operate 1,500 HealthHUBs by the end of 2021. CVS fills or manages 2.5 billion prescriptions.
Meanwhile, Walmart, which has around 265 million weekly shoppers globally, launched its first clinic in 2019 providing primary medical services, dental care, vision care and behavioral health services, alongside health education and wellness programs. The retailer has opened 20 standalone healthcare centers with plans to open 15 more in 2021, part of a strategy to open 4,000 clinics by 2029.
Not to be left behind, Walgreens has partnered with VillageMD to open 500 to 700 doctors’ offices in stores, while Kroger operates approximately 215 Little Clinics in its grocery stores.
We believe these local healthcare facilities will play a major role in the transformation of R&D. Retail clinics and community practices have the capabilities to support trials in far more disease areas than virtual approaches alone.
Retail health clinics are generally located closer to participants’ homes and places of work than large clinical trial sites, affording patients the flexibility to tailor their trial experience to their needs and preferences. A survey2 reported that 80% of patients said they would join clinical trials if the site was 30 minutes or less from home.
Furthermore, national retail pharmacies and retail health clinics/physician practices have far more opportunities to engage with potential trial participants and access to additional data that could inform targeted recruitment efforts.
2 source: The Washington State Office of Financial Management, accessed October, 2021
Retail clinics and community practices have the capabilities to support trials in far more disease areas than virtual approaches alone.
Evolution of the decentralized trial approaches
The industry has been experimenting with innovative ways to deliver clinical trials for years, but has failed to make decentralized trials the industry norm, most previous efforts did not progress beyond experimentation and piloting. COVID-19 has been the catalyst that pushed the industry to innovate.
In some instances, pharma companies have not gone far enough, relying on models that weren’t applicable across a diverse set of therapeutic areas and didn’t fully address patient needs. Home-based care models are often considered too invasive by patients who oppose bringing medical care providers into their homes. Meanwhile, virtual care has been adopted at some level across the industry, but not in the form of fully virtualized trials, which come up against everything from technology challenges to limited feasibility for certain therapeutic areas to a lack of medical staff in the event of an emergency.
Yet shifts to the greater landscape, largely driven by disruptions to care during the height of the pandemic, could help decentralized trials become more mainstream. Further evidence that this model is likely to become more entrenched:
- Large players are investing. With BioPharma on the national stage, large players including CVS have entered the decentralized trial space. Large rounds of $100M+ in funding for companies including Medable, Science 37 and THREAD have set the tone that the decentralized trial market is rapidly evolving.
- Business continuity demands it. Decentralized trials are a necessary business continuity strategy to prevent the massive disruptions caused by COVID-19 from occurring again.
- The regulatory environment is shifting. Global agencies led by the FDA and EMEA are accelerating the issuance of guidance to accelerate the market and signal willingness to think differently from a regulatory and compliance standpoint.
- Infrastructure investments are already being made. Biopharma companies have already started making significant investments to develop strategies and build the infrastructure (centers of excellence, processes and technology) to scale decentralized trials across their portfolios.
Moving from traditional delivery to future state of decentralized clinical trials
Improved access: Large national retail pharmacies, health clinics and community practices have a broader geographic reach and exponentially more opportunities to engage with patients than academic medical centers and research hospitals. This will vastly increase the number of potential participants made aware of the trials they may qualify for and enable them to complete screening and enrollment activities in their local communities.
Flexibility: The ability to complete trial activities virtually, at home, and multiple local sites (with proximity to work, home or vacation) will make it much easier for patients to participate in trials without significantly disrupting their daily lives.
Reduced burden: Access, proximity and flexibility will make it much easier for trial participants to learn about potential trials, enroll in and complete trials per the protocol.
Accelerated trial delivery: National retail pharmacies, health clinics and community practices have extensive reach, exponentially more opportunities to engage potential participants and digital capabilities that will accelerate recruitment. These decentralized networks can be started up in days or weeks versus months, which will materially reduce trial cycle times.
Improved patient retention: Increased flexibility, reduced burden and improved experience will help reduce patient dropout rates.
Recruit representative populations: According to mdgroup3, 50% of FDA clinical trials in the US are conducted in 1% to 2% of ZIP codes. Decentralized site networks will expand the geographic reach to communities that historically have not had access to clinical trials. Recruiting underrepresented populations into clinical trials is a complex issue, enabling access and helping to alleviate logistical challenges and patient burden is a significant first step that will improve sponsors’ ability to recruit representative populations into their trials.
3 source: mdgroup.com, accessed October, 2021
Increase access and expand capacity: Establishing and expanding a network of sites in new localities will provide new access opportunities for patients that have been historically difficult to reach that will accelerate trial recruitment and increase opportunities to have a more significant role in more trials.
Create new revenue streams: Primary investigators can oversee significantly more participants and visits on trials through partnerships with community practices and retail health clinics as well as technology providers (i.e., Medable, Science 37, THREAD) that make it possible for trial activities to be delivered locally and virtually.
Expand clinical research pipelines: Having access to large, geographically diverse site networks will increase the number of individuals who can be recruited for trials. This format also enhances providers’ ability to recruit more widely for investigator-sponsored studies, support the setup of registries and conduct large real world evidence-based research. These expanded patient volumes can lead to stronger research findings and higher likelihood of publication.
How PwC can help
PwC has been supporting the bleeding edge of clinical development operations for over a decade across operating model design, CRO strategy, advanced analytics, and decentralized trials. The R&D practice has led the development of innovative decentralized trial market offerings as well as supported sponsors in evaluating strategic fit for their portfolios. For this, PwC has developed a proprietary capability that uses analytics and natural language processing (NLP) to assess endpoints and to identify the optimal assets and disease areas for decentralization. In addition, PwC has developed a deep understanding of the ancillary impacts of decentralized trials (data aggregation/integration, trial and multi-provider oversight powered by data automation and AI, etc.) that require infrastructure to support a compliant and safe trial execution strategy.
With this experience coupled with the PwC’s technology enabled service offering, we can expedite the process of developing a new product market opportunity or evaluate decentralized clinical trials as an opportunity for sponsors seeking entry into the decentralized trial space.
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